scholarly journals Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ali Ameri ◽  
Masoomeh Frouz Asadi ◽  
Manoochehr Kamali ◽  
Majid Vatankhah ◽  
Ava Ziaei ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Mechanical Ventilation ◽  
Intensive Care ◽  
Standard Treatment ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Full Protocol ◽  
Bandar Abbas

Abstract Objectives We investigate the effects of melatonin, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in severely ill patients with confirmed COVID-19 who are admitted to the Intensive Care Unit (ICU). Trial design This is a single-center, open-label, randomized, clinical trial with a parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria 1. Age >20 years 2. Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing 3. Severe pneumonia and lung involvement in imaging 4. Signing informed consent Exclusion criteria 1. Underlying diseases, including convulsive disorders, chronic hepatic and renal diseases 2. Use of mechanical ventilation 3. History of known allergy to Melatonin 4. Pregnancy and breastfeeding Intervention and Comparator Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education’s protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company) at a dose of 5 mg twice a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education’s protocol for a period of seven days. Main outcomes The primary outcomes are the recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH) within seven days of randomization. The secondary outcomes are time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate within seven days of randomization. Randomization Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 6 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). Trial Status The protocol is Version 1.0, February 16, 2021. Recruitment began February 28, 2021, and is anticipated to be completed by July 31, 2021. Trial registration The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N7”. The registration date was February 16, 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Omid Safa ◽  
Mehdi Hassani-Azad ◽  
Mehdi Farashahinejad ◽  
Parivash Davoodian ◽  
Habib Dadvand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Treatment ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Control Group ◽  
Root Extract ◽  
Open Label ◽  
Natural Medicine ◽  
Full Protocol ◽  
Bandar Abbas

Abstract Objectives We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria. Inclusion criteria: 1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm. Exclusion criteria: 1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding. Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days. Main outcomes The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization. Randomization An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). Trial Status The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N2”, https://www.irct.ir/trial/47990. The registration date is 31 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mehdi Hassaniazad ◽  
Ali Bazram ◽  
Soheil Hassanipour ◽  
Mohammad Fathalipour
Keyword(s):  
Interferon Beta ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
List Type ◽  
Peptic Ulcers ◽  
Efficacy And Safety ◽  
Open Label ◽  
Full Protocol ◽  
Bandar Abbas

Abstract Objectives We will evaluate the efficacy and safety of favipiravir and interferon beta-1a compared to lopinavir/ritonavir and interferon beta-1a in patients with confirmed COVID-19, who are moderately ill. Trial design This is a phase 3, single-center, randomized, open-label, controlled trial with a parallel-group design carried out at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients with age ≥ 20 years admitted at the Severe Acute Respiratory Syndrome Departments of the Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria: Confirmed diagnosis of infection with SARS-CoV-2 using polymerase chain reaction and/or antibody tests. Moderate COVID-19 pneumonia (via computed tomography and/or X-ray imaging), requiring hospitalization. Hospitalized ≤ 48 h. Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm. Exclusion criteria: Underlying conditions, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, peptic ulcers, acute and chronic renal failure, and peptic ulcers. Severe and critical COVID-19 pneumonia. History of allergy to favipiravir, lopinavir/ritonavir, and interferon beta-1a. Pregnancy and breastfeeding. Intervention and comparator Intervention group: favipiravir (Zhejiang Hisun, China) with interferon beta-1a (CinnaGen, Iran). This group will receive 1600 mg favipiravir twice a day for the first day and 600 mg twice a day for the following 4 days with five doses of 44 mcg interferon beta-1a every other day. Control group: lopinavir/ritonavir (Heterd Company, India) with interferon beta-1a (CinnaGen, Iran). This group will receive 200/50 mg lopinavir/ritonavir twice a day for 7 days with five doses of 44 mcg interferon beta-1a every other day. Other supportive and routine care will be the same in both groups. Main outcomes The primary outcome of the trial is the viral load of SARS-CoV-2 in the nasopharyngeal samples assessed by RT-PCR after 7 days of randomization as well as clinical improvement of fever and O2 saturation within 7 days of randomization. The secondary outcomes are the length of hospital stay and the incidence of serious adverse drug reactions within 7 days of randomization. Randomization Eligible patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 10 patients). A web-based system will be used to generate random numbers for the allocation sequence. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 patients will be randomized into two groups (30 patients in the intervention group and 30 patients in the control group). Trial status The trial protocol is version 1.0, 22 July 2020. Recruitment began on 25 July 2020 and is anticipated to be completed by 25 September 2020. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20200506047323N3. Registered on 22 July 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.

scholarly journals The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Arash Rahimi ◽  
Hamid Reza Samimagham ◽  
Mehdi Hassani Azad ◽  
Dariush Hooshyar ◽  
Mohsen Arabi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Pharmaceutical Company ◽  
Study Protocol ◽  
Intervention Group ◽  
Phase Iii ◽  
Arterial Oxygen ◽  
Control Group ◽  
Full Protocol

Abstract Objectives Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors, increased reactive oxygen species, and cell damage. In addition to mucolytic effects, N-Acetylcysteine has antioxidant effects that we believe can help patients recover. In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19. Trial design This is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group. Participants All severe COVID-19 patients with at least one of the following five conditions: (respiration rate > 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH) > 245 U / l, Progressive lymphopenia, and admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas and have positive PCR test results for SARS-Cov-2 and sign the written consent of the study will be included. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study. Intervention and comparator After randomization, participants in the intervention group receive standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline for parenteral injection (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 gr as a slow single intravenous injection on the first day of hospitalization. In the control group patients receive SOC and placebo ( Sterile water for injection as the same dose). The placebo is identical in appearance to the N-acetylcysteine injection (EXIR pharmaceutical company as well). Main outcomes The primary endpoint for this study is a composite endpoint for the length of hospitalization in the intensive care unit and the patient's clinical condition. These outcomes were measured at the baseline (before the intervention) and on the 14th day after the intervention or on the discharge day. Randomisation Eligible participants (40) will be randomized in two arms in the ratio of 1: 1 (20 per arm) using online web-based tools and by permuted block randomization method. To ensure randomization concealment, random sequence codes are assigned to patients by the treatment team at the time of admission without knowing that each code is in the intervention or comparator group. Blinding (masking) All participants will be informed about participating in the study and the possible side effects of medication and placebo. Patients participating in the study will not be aware of the assignment to the intervention or control group. The principal investigator, health care personnel, data collectors, and those evaluating the outcome are aware of patient grouping. Numbers to be randomised (sample size) A total of 40 patients participate in this study, which are randomly divided; 20 patients in the intervention group will receive SOC and N-acetylcysteine, 20 patients in the control group will receive SOC and placebo. Trial status First version of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on February 14, 2021, with the local code 990573, and the recruitment started on March 2, 2021 and the expected recruitment end date is April 1, 2021. Trial registration The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3, at Iranian Registry of clinical trials on 20 February 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

scholarly journals INVESTIGATING EFFECT OF NURSING INTERVENTIONS, BASED ON WELLS SCORE RESULTS, ON THE INCIDENCE OF DEEP VEIN THROMBOSIS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

2018 ◽  
Vol 11 (5) ◽  
pp. 377
Author(s):  
Morteza Habibi Moghadam ◽  
Marzieh Asadizaker ◽  
Simin Jahani ◽  
Elham Maraghi ◽  
Hakimeh Saadatifar ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Deep Vein Thrombosis ◽  
Intervention Group ◽  
Control Group ◽  
Nursing Interventions ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Deep Vein ◽  
Pitting Edema

 Objective: Venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complaint in critically ill patients. Therefore, the present study was conducted to determine the effect of nursing interventions, based on the Wells results, on the incidence of DVT in intensive care unit (ICU) patients.Methods: The present clinical trial was conducted on 72 ICU patients without DVT and PE who met the inclusion criteria according to Wells score in Dr. Ganjavian Hospital, Dezful in 2012. The participants were investigated and randomly divided into intervention (n=36) and control groups (n=36). The intervention group received preventive nursing measures based on the risk level determined by the Wells score, and routine therapeutic interventions were performed for the control group. Then, patients were evaluated using Wells score, D-dimer testing, and Doppler sonography on the 1st, 5th, and 10th days. Data were finally coded and entered into SPSS version 23. Data analysis was performed using Chi-square, Fisher’s exact, and Mann–Whitney U tests.Results: The incidence of DVT in both groups showed that 2 patients of the control group who were identified to be at risk using the Wells score were diagnosed with DVT while none of the patients of the intervention group experienced DVT. The present study showed that 22.2% of the patients of the control group suffered from non-pitting edema, which was significantly different from the intervention group (p=0.005).Conclusion: The results of the present study showed that using the Wells score for early identification of the at-risk patients and nursing interventions based on this score’s results is helpful in the prevention of DVT. Appropriate nursing interventions were also effective in reducing the incidence of non-pitting edema in the lower extremities.

scholarly journals A CLINICAL STUDY TO ASSESS THE EFFICACY OF SHWASAHARA DASHEMANI GHANAVATI IN CARDIAC ASTHMA W.S.R L.V.F

2021 ◽  
Vol p6 (1) ◽  
pp. 3179-3185
Author(s):  
Roopa M.R ◽  
Vasudev A Chate ◽  
Shreevathsa Shreevathsa ◽  
Mohan Kumar G
Keyword(s):  
Standard Treatment ◽  
Intervention Group ◽  
Simple Random Sampling ◽  
Control Group ◽  
P Value ◽  
Common Symptom ◽  
Open Label ◽  
Post Test ◽  
Clinically Significant ◽  
Cardiac Asthma

Introduction: Shwasa is said as Shigrapranahara Roga. It occurs as the main disease and also a symptom in various diseases. Shwasakruchrata is a common symptom that occurs in Hrudroga. Acharya Charaka mentioned the unique classification of drugs based on their action. Shwasahara Dashemani is one among them. It is containing 10 herbal drugs which are specially indicated in Shwasa Roga. Hence to evaluate the efficacy of Shwasahara Dashemani in Lakshana Roopi Shwasa in L.V.F (Cardiac Asthma) has taken for the study. Aim and Objective: The objective is to assess the efficacy of Shwasahara Dashemani in L.V.F with dyspnea (Cardiac Asthma). Method: The present study is a controlled comparative, open-label, clinical trial with pre and post-test design. A total of 40 subjects of a diagnosed case of L.V.F with dyspnea (Cardiac Asthma) were selected by using a simple random sampling method. Control group subjects were intervened with standard treatment of L.V.F and intervention group subjects were intervened with standard treatment of L.V.F along with Shwasahara Dashemani Ghana Vati, for the duration of 30 days. Its efficacy was assessed before treatment (0th day) and after treatment (31st day) by using BDI (Baseline Dyspnea Index Scale). Results: The P-value of dyspnea of the control group is 1.000 and the P-value of dyspnea of the intervention group is 0.105. This shows that the results of both groups are statistically not significant. But as compared to the control group, the intervention group is clinically significant because after the intervention 35% of subjects had shown improvement in the intervention group. Conclusion: As compared to the control group, in the intervention group Shwasahara Dashemani Ghanavati is clinically significant in relieving cardiac asthma when used with standard treatment of L.V.F. Keyword: Shwasahara Dashemani. Cardiac Asthma, L.V.F, Dyspnea

Improving Family Communications at the End of Life: Implications for Length of Stay in the Intensive Care Unit and Resource Use

2003 ◽  
Vol 12 (4) ◽  
pp. 317-324 ◽  
Author(s):  
Tom Ahrens ◽  
Valerie Yancey ◽  
Marin Kollef
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Length Of Stay ◽  
End Of Life ◽  
Resource Utilization ◽  
Intervention Group ◽  
Clinical Nurse Specialist ◽  
Control Group ◽  
Nurse Specialist ◽  
Clinical Nurse

• Background Inadequate communication persists between healthcare professionals and patients and patients’ families in intensive care units. Unwanted or ineffective treatments can occur when patients’ goals of care are unknown or not honored, increasing costs and care. Having the primary physician provide medical information and then having a physician and clinical nurse specialist team improve opportunities for patients and their families to process that information could improve the situation. This model has not been tested for its effect on patients’ outcomes and resource utilization.• Objectives To evaluate the effect of a communication team that included a physician and a clinical nurse specialist on length of stay and costs for patients near the end of life in the intensive care unit.• Methods During a 1-year period, patients judged to be at high risk for death (N = 151) were divided into 2 groups: 43 patients who were cared for by the medical director teamed with a clinical nurse specialist and 108 patients who received standard care, provided by an attending physician.• Results Compared with the control group, patients in the intervention group had significantly shorter stays in both the intensive care unit (6.1 vs 9.5 days) and the hospital (11.3 vs 16.4 days) and had lower fixed ($15 559 vs $24 080) and variable ($5087 vs $8035) costs.• Conclusions Use of a physician and a clinical nurse specialist focused on improving communication with patients and patients’ families reduced lengths of stay and resource utilization.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery

2016 ◽  
Vol 124 (4) ◽  
pp. 826-836 ◽  
Author(s):  
Alain Deschamps ◽  
Richard Hall ◽  
Hilary Grocott ◽  
C. David Mazer ◽  
Peter T. Choi ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Intervention Group ◽  
Perioperative Outcomes ◽  
Control Group ◽  
Cerebral Oxygen ◽  
Cerebral Desaturation ◽  
Cerebral Saturation

Abstract Background Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Methods Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Results Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, −294; 95% CI, −562 to −26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Conclusions Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

A Randomized, Open-Label Study of the Safety and Tolerability of Fospropofol for Patients Requiring Intubation and Mechanical Ventilation in the Intensive Care Unit

2012 ◽  
Vol 56 (3) ◽  
pp. 111-112
Author(s):  
Keith A. Candiotti ◽  
Tong J. Gan ◽  
Christopher Young ◽  
Alex Bekker ◽  
S.T. John Sum-Ping ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Mechanical Ventilation ◽  
Intensive Care ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals A Randomized Open-Label Trial To Evaluate The Efficacy And Safety Of Triple Therapy With Aspirin, Atorvastatin, And Nicorandil In Hospitalised Patients With SARS Cov-2 Infection: A Structured Summary Of A Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Ambudhar Sharma ◽  
Charu Sharma ◽  
Sujeet Raina ◽  
Balraj singh ◽  
Devendra Singh Dadhwal ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Hospital Discharge ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Once Daily ◽  
Starting Dose ◽  
Full Protocol ◽  
Open Label Trial ◽  
And Control

Abstract ObjectivesThe pathophysiology of SARS-Cov-2 is characterized by inflammation, immune dysregulation, coagulopathy, and endothelial dysfunction. No single therapeutic agent can target all these pathophysiologic substrates. Moreover, the current therapies are not fully effective in reducing mortality in moderate and severe disease. Hence, we aim to evaluate the combination of drugs (aspirin, atorvastatin, and nicorandil) with anti-inflammatory, antithrombotic, immunomodulatory, and vasodilator properties as adjuvant therapy in covid- 19.Trial designSingle-centre, prospective, two-arm parallel design, open-label randomized control superiority trial. ParticipantsThe study will be conducted at the covid centre of Dr. Rajendra Prasad Government Medical College Tanda Kangra, Himachal Pradesh, India. All SARS-CoV-2 infected patients requiring admission to the study centre will be screened for the trial. All patients >18years who are RT-PCR/RAT positive for SARS-CoV-2 infection with pneumonia but without ARDS at presentation (presence of clinical features of dyspnoea hypoxia, fever, cough, spo2 <94% on room air and respiratory rate >24/minute) requiring hospital admission and consenting to participate in the trial will be included.Patients with documented significant liver disease/dysfunction (AST/ALT > 240), myopathy and rhabdomyolysis (CPK > 5x normal), allergy or intolerance to statins, allergy or intolerance to aspirin, patients taking medications with significant interaction with statins, prior statin use (within 30 days), prior aspirin use (within 30 days), history of active GI bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, patient unable to take oral or nasogastric medications, patients in altered mental status, shock, acute renal failure, acute coronary syndrome, sepsis and ARDS at presentation will be excluded. Intervention and comparatorAfter randomization, participants in the intervention group will receive aspirin, atorvastatin, and nicorandil. Atorvastatin will be prescribed as 40 mg starting dose followed by 40 mg oral tablets once daily for ten days or till hospital discharge whichever is later. Aspirin dose will be 325 starting dose followed by 75 mg once daily for ten days or till hospital discharge whichever is later. Nicorandil will be given as 10 mg starting dose followed by 5mg twice daily ten days or till hospital discharge whichever is later. All patients in the intervention and control group will receive a standard of care for covid management as per national guidelines. All patients will receive symptomatic treatment with antipyretics, adequate hydration, anticoagulation with low molecular weight heparin, intravenous remdesivir, corticosteroids (intravenous dexamethasone for 5 days or more duration if oxygen requirement increasing or inflammatory markers are raised), and oxygen support. Patients will receive treatment for comorbid conditions as per guidelines.Main outcomesThe patients will be followed up for outcomes during the hospital stay or for ten days whichever is longer. The primary outcome will be in-hospital mortality. Any progression to ARDS, shock, acute kidney injury, impaired consciousness, length of hospital stay, length of mechanical ventilation (invasive plus non-invasive) will be secondary outcomes. Changes in serum markers (CRP, D –dimer, S ferritin) will be other secondary outcomes. The safety endpoints will be hepatotoxicity (ALT/AST > 3x ULN; hyperbilirubinemia), myalgia—muscle ache, or weakness without creatine kinase (CK) elevation, myositis—muscle symptoms with increased CK levels (3-10) ULN, rhabdomyolysis—muscle symptoms with marked CK elevation (typically substantially greater than 10 times the upper limit of normal [ULN]) and with creatinine elevation (usually with brown urine and urinary myoglobin) observed during the hospital stay. RandomizationComputer-generated block randomization will be used to randomize the participants in a 1:1 ratio to the active intervention group A (Aspirin, Atorvastatin, Nicorandil) plus conventional therapy and control group B conventional therapy only. Blinding (masking)The study will be an open-label trial. Numbers to be randomized (sample size)A total of 396 patients will participate in this study, which is randomly divided with 198 participants in each group.Trial statusThe first version of the protocol was approved by the institutional ethical committee on 1st February 2021, IEC /006/2021. The recruitment started on 8/4/2021 and will continue until 08/07/2021. A total of 281 patients have been enrolled till 21/5/2021.Trial registrationThe trial has been prospectively registered in Clinical Trial Registry – India (ICMR- NIMS): CTRI/2021/04/032648 [Registered on: 08/04/2021].Full protocolThe full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported under the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

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