scholarly journals Coadministration of AYUSH 64 as an adjunct to Standard of Care in mild and moderate COVID-19: A randomised, controlled, multicentric clinical trial

2021 ◽  
Author(s):  
Arvind Chopra ◽  
Girish Tillu ◽  
Kuldeep Chaudhary ◽  
Govind Reddy ◽  
Alok Srivastava ◽  
...  
Keyword(s):  
Teaching Hospital ◽  
College Teaching ◽  
Standard Of Care ◽  
Time Frame ◽  
University Teaching ◽  
National Guidelines ◽  
Open Label ◽  
Chi Square ◽  
Convenience Sample ◽  
Randomised Controlled

Objectives: To compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19. Design: Multicentre, parallel efficacy, randomized, controlled, open-label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration. Setting: COVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospital Participants: 140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if the disease becomes severe. Interventions: Two tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease. Main outcome measures: Time period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocol Results: 140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (p<0.05) superior persistent improvement in general health, quality of life, fatigue, anxiety, stress, sleep, and other psychosocial metrics. 1 patient on SOC required critical care. 48 adverse events (AE) reported in each group. Barring three SAE (in SOC), AE were mild and none were drug-related. 22 participants (8 on AYUSH) were withdrawn. No deaths were reported. Conclusions: AYUSH 64 hastened recovery, reduced hospitalization, and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well-tolerated. Further studies are warranted. Trial registration: The Clinical Trials Registry India Number CTRI/2020/06/025557 Funding: CCRAS, Ministry of AYUSH, Government of India

scholarly journals Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Adeniyi Olagunju ◽  
Adeola Fowotade ◽  
Ajibola Olagunoye ◽  
Temitope Olumuyiwa Ojo ◽  
Bolanle Olufunlola Adefuye ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
University Teaching ◽  
Chain Reaction ◽  
Open Label ◽  
Link Type ◽  
Care Facilities ◽  
Full Protocol ◽  
Polymerase Chain ◽  
Randomised Controlled

Abstract Objectives To investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in shortening the time to clinical improvement and achievement of SARS-CoV-2 polymerase chain reaction (PCR) negativity in patients diagnosed with moderate to severe COVID-19. Trial design This is a pilot phase 2, multicentre 2-arm (1:1 ratio) open-label randomised controlled trial. Participants Patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 PCR positive nasopharyngeal swab) will be recruited from four participating isolation and treatment centres in Nigeria: two secondary care facilities (Infectious Diseases Hospital, Olodo, Ibadan, Oyo State and Specialist State Hospital, Asubiaro, Osogbo, Osun State) and two tertiary care facilities (Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Osun State and Olabisi Onabanjo University Teaching Hospital, Sagamu, Ogun State). These facilities have a combined capacity of 146-bed COVID-19 isolation and treatment ward. Inclusion criteria Confirmation of SARS-CoV-2 infection by PCR test within two days before randomisation and initiation of treatment, age bracket of 18 and 75 years, symptomatic, able to understand study information and willingness to participate. Exclusion criteria include the inability to take orally administered medication or food, known hypersensitivity to any of the study drugs, pregnant or lactating, current or recent (within 24 hours of enrolment) treatment with agents with actual or likely antiviral activity against SARS-CoV-2, concurrent use of agents with known or suspected interaction with study drugs, and requiring mechanical ventilation at screening. Intervention and comparator Participants in the intervention group will receive 1000 mg of nitazoxanide twice daily orally and 300/100 mg of atazanvir/ritonavir once daily orally in addition to standard of care while participants in the control group will receive only standard of care. Standard of care will be determined by the physician at the treatment centre in line with the current guidelines for clinical management of COVID-19 in Nigeria. Main outcome measures Main outcome measures are: (1) Time to clinical improvement (defined as time from randomisation to either an improvement of two points on a 10-category ordinal scale (developed by the WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection) or discharge from the hospital, whichever came first); (2) Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at days 2, 4, 6, 7, 14 and 28; (3) Temporal patterns of SARS-CoV-2 viral load on days 2, 4, 6, 7, 14 and 28 quantified by RT-PCR from saliva of patients receiving standard of care alone versus standard of care plus study drugs. Randomisation Allocation of participants to study arm is randomised within each site with a ratio 1:1 based on randomisation sequences generated centrally at Obafemi Awolowo University. The model was implemented in REDCap and includes stratification by age, gender, viral load at diagnosis and presence of relevant comorbidities. Blinding None, this is an open-label trial. Number to be randomised (sample size) 98 patients (49 per arm). Trial status Regulatory approval was issued by the National Agency for Food and Drug Administration and Control on 06 October 2020 (protocol version number is 2.1 dated 06 August 2020). Recruitment started on 9 October 2020 and is anticipated to end before April 2021. Trial registration The trial has been registered on ClinicalTrials.gov (July 7, 2020), with identifier number NCT04459286 and on Pan African Clinical Trials Registry (August 13, 2020), with identifier number PACTR202008855701534. Full protocol The full protocol is attached as an additional file which will be made available on the trial website. In the interest of expediting dissemination of this material, the traditional formatting has been eliminated, and this letter serves as a summary of the key elements in 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 Stigmatising attitudes towards the mentally ill: A survey in a Nigerian university teaching hospital

2010 ◽  
Vol 16 (2) ◽  
pp. 5 ◽  
Author(s):  
Dominic Ignatius Ukpong ◽  
Festus Abasiubong
Keyword(s):  
Mental Illness ◽  
Teaching Hospital ◽  
Low Income ◽  
Mentally Ill ◽  
Educational Programme ◽  
University Teaching ◽  
Low Income Countries ◽  
Cross Sectional ◽  
Convenience Sample ◽  
Nigerian University

<p><strong>Background.</strong> The burden of mental illness is particularly severe for people living in low-income countries. Negative attitudes towards the mentally ill, stigma experiences and discrimination constitute part of this disease burden.</p><p><strong>Objective.</strong> The aim of this study was to investigate knowledge of possible causes of mental illness and attitudes towards the mentally ill in a Nigerian university teaching hospital population.</p><p><strong>Method.</strong> A cross-sectional descriptive study of a convenience sample of 208 participants from the University of Uyo Teaching Hospital, Uyo, Nigeria, using the Community Attitudes towards the Mentally Ill (CAMI) scale. Information was also obtained on beliefs about possible causes of mental illness. <strong></strong></p><p><strong>Results.</strong> The respondents held strongly negative views about the mentally ill, mostly being authoritarian and restrictive in their attitudes and placing emphasis on custodial care. Even though the respondents appeared to be knowledgeable about the possible role of psychosocial and genetic factors in the causation of mental illness, 52.0% of them believed that witches could be responsible, 44.2% thought mental illness could be due to possession by demons, and close to one-third (30%) felt that it could be a consequence of divine punishment.</p><p><strong>Conclusions.</strong> Stigma and discrimination against the mentally ill are widespread even in a population that is expected to be enlightened. The widespread belief in supernatural causation is likely to add to the difficulties of designing an effective anti-stigma psycho-educational programme. There is a need in Nigeria to develop strategies to change stigma attached to mental illness at both institutional and community levels.</p>

scholarly journals Clinical and biological profiles of older adults aged 50 and over compared to those under 50 in people living with HIV attending Kinshasa University Teaching Hospital (DR Congo)

2021 ◽  
Vol 5 (2) ◽  
pp. 087-095
Author(s):  
Mbula MMK ◽  
Longo-Mbenza B ◽  
Situakibanza HNT ◽  
Mananga GL ◽  
Makulo JRR ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Teaching Hospital ◽  
University Teaching ◽  
People Living With Hiv ◽  
Chi Square ◽  
Stage 4 ◽  
History Of ◽  
Student’S T ◽  
Living With Hiv ◽  
Student’S T Test

Background: The survival of people living with HIV (PLWHIVs) is increased and Health systems will have to deal with the early-aging-associated medical conditions. Objective: The objective of this study is to compare the clinical and biological profiles of PLWHIVs aged 50 and over and those aged less than 50 years. Material and methods: This study conducted at Kinshasa University Teaching Hospital (KUTH) covers 6 years. The clinical and biological characteristics of PLWHIVs aged 50 and over were compared with those under 50. Statistical analysis used the means ± SD, the calculation of frequencies, Student’s t-test and Chi-square. Results: PLWHIVs aged 50 or over represented 35.1%. Their average age was 58.0 ± 4.8 years. Women predominate among those under 50 and men among those 50 and over. Married people were more numerous (54% among those under 50). There were more unemployed (50% of PLHIV under 50). Patients 50 years and older were significantly classified as WHO stage 4 with a high frequency of history of tuberculosis, genital herpes, high blood pressure, smoking, vomiting, hepatomegaly, moderate elevation of diastolic blood pressure (DBP) and sytolic blood pressure (SBP), tuberculosis and anemia. Those under 50 had a significantly increased frequency of shingles, hepatitis B-hepatitis C, headaches and more survivals. The mean of Hb, HDL-C, and CD4s+ were significantly lower in patients 50 years and older, and urea, LDL-C, and ALAT levels were significantly higher. Conclusion: The average age was higher from 50 years old. These PLWHIVs were more frequently in WHO stage 4 with more common TB and anemia. Their Hb, HDL-C, and CD4s+ levels were lower while their urea, LDL-C and ALAT levels were significantly elevated.

scholarly journals Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

2021 ◽  
Author(s):  
Peter W Horby ◽  
Guilherme Pessoa-Amorim ◽  
Natalie Staplin ◽  
Jonathan R Emberson ◽  
Enti Spata ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Rate Ratio ◽  
Invasive Mechanical Ventilation ◽  
Standard Of Care ◽  
Open Label ◽  
Absolute Increase ◽  
Significant Difference ◽  
Randomised Controlled ◽  
To Receive

Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its antithrombotic properties. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus 150mg aspirin once daily until discharge using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 01 November 2020 and 21 March 2021, 7351 patients were randomly allocated to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to usual care died within 28 days (rate ratio 0.96; 95% confidence interval [CI] 0.89-1.04; p=0.35). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1.06; 95% CI 1.02-1.10; p=0.0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0.96; 95% CI 0.90-1.03; p=0.23). Aspirin use was associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an absolute increase in clinically significant bleeding of 0.6% (SE 0.2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death but was associated with a small increase in the rate of being discharged alive.

BioMed_Central_Tex_Template_v1.06 Exploration of Workplace violence experience among nurses at a selected University teaching Hospital in Rwanda

2019 ◽  
Author(s):  
Valens MUSENGAMANA ◽  
Oluyinka Adejumo ◽  
Gilbert BANAMWANA ◽  
Marie Josée MUKAGENDANEZA ◽  
Thimothée Shahidi TWAHIRWA
Keyword(s):  
Teaching Hospital ◽  
Workplace Violence ◽  
Health Sector ◽  
University Teaching ◽  
World Health ◽  
Research Approach ◽  
International Labor Organization ◽  
Chi Square ◽  
Cross Sectional ◽  
Health Organization

Abstract Background Workplace violence is a global problem in the health sector especially in the hospitals affecting healthcare works’ job satisfaction and performance. Workplace violence is present in different forms associated with various factors and the nurses are the most affected. The aim of this study was to explore workplace violence experience among nurses working at a selected University Teaching Hospital in Rwanda.Method The research approach used was quantitative descriptive cross-sectional design. The stratified random sampling was used to recruit 195 participants among 379 nurses. The data was collected using a structured, validated, and self-administered questionnaire that was adapted from the International Labor Organization, International Council of Nurses, World Health Organization and Public Services International. Descriptive statistics were used for analyzing frequencies and percentages. Chi-square test was used for evaluating the association between variables.Results The findings revealed that (58.5%, n=114) of nurses have experienced some types of WPV in the twelve months preceding the study, among them (44.6%, n=108) of nurses were verbally abused. The nurses providing emergency care, the nurses working at the emergency department and nurses working with vulnerable patients like HIV/AIDS patients were associated with workplace violence Chi-square (1, n=195), P=<0.001). The psychological problems has been found as the first consequences of workplace violence.Conclusions Based on the study findings, it was concluded that the hospital management needs to be aware of workplace violence, develop and implement appropriate policies and strategies. These strategies will strengthen nurses’ concentration towards their and will resulting in service delivery improvement.

scholarly journals High dose oral and intravenous rifampicin for improved survival from adult tuberculous meningitis: a phase II open-label randomised controlled trial (the RifT study)

2018 ◽  
Vol 3 ◽  
pp. 83 ◽  
Author(s):  
Fiona V. Cresswell ◽  
Kenneth Ssebambulidde ◽  
Daniel Grint ◽  
Lindsey te Brake ◽  
Abdul Musabire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Hiv Positive ◽  
Current Standard ◽  
Open Label ◽  
Dose Oral ◽  
Randomised Controlled ◽  
Positive Population

Background: Tuberculous meningitis (TBM) has 44% (95%CI 35-52%) in-hospital mortality with standard therapy in Uganda. Rifampicin, the cornerstone of TB therapy, has 70% oral bioavailability and ~10-20% cerebrospinal fluid (CSF) penetration.  With current WHO-recommended TB treatment containing 8-12mg/kg rifampicin, CSF rifampicin exposures frequently fall below the minimal inhibitory concentration for M. tuberculosis. Two Indonesian phase II studies, the first investigating intravenous rifampicin 600mg and the second oral rifampicin ~30mg/kg, found the interventions were safe and resulted in significantly increased CSF rifampicin exposures and a reduction in 6-month mortality in the investigational arms. Whether such improvements can be replicated in an HIV-positive population remains to be determined. Protocol: We will perform a phase II, open-label randomised controlled trial, comparing higher-dose oral and intravenous rifampicin with current standard of care in a predominantly HIV-positive population. Participants will be allocated to one of three parallel arms (I:I:I): (i) intravenous rifampicin 20mg/kg for 2-weeks followed by oral rifampicin 35mg/kg for 6-weeks; (ii) oral rifampicin 35mg/kg for 8-weeks; (iii) standard of care, oral rifampicin 10mg/kg/day for 8-weeks. Primary endpoints will be: (i) pharmacokinetic parameters in plasma and CSF; (ii) safety. We will also examine the effect of higher-dose rifampicin on survival time, neurological outcomes and incidence of immune reconstitution inflammatory syndrome. We will enrol 60 adults with suspected TBM, from two hospitals in Uganda, with follow-up to 6 months post-enrolment. Discussion: HIV co-infection affects the bioavailability of rifampicin in the initial days of therapy, risk of drug toxicity and drug interactions, and ultimately mortality from TBM. Our study aims to demonstrate, in a predominantly HIV-positive population, the safety and pharmacokinetic superiority of one or both investigational arms compared to current standard of care. The most favourable dose may ultimately be taken forward into an adequately powered phase III trial. Trial registration: ISRCTN42218549 (24th April 2018)

scholarly journals Azithromycin in Hospitalised Patients with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

2020 ◽  
Author(s):  
Peter W Horby ◽  
Alistair Roddick ◽  
Enti Spata ◽  
Natalie Staplin ◽  
Jonathan R Emberson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Rate Ratio ◽  
Invasive Mechanical Ventilation ◽  
Composite Endpoint ◽  
Standard Of Care ◽  
Open Label ◽  
Hospitalised Patients ◽  
Randomised Controlled ◽  
To Receive

Background: Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatory actions. We evaluated the efficacy and safety of azithromycin in hospitalised patients with COVID-19. Methods: In this randomised, controlled, open-label, adaptive platform trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19 in the UK. Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once daily by mouth or intravenously for 10 days or until discharge (or one of the other treatment arms). Patients were twice as likely to be randomised to usual care as to any of the active treatment groups. The primary outcome was 28-day mortality. Findings: Between 7 April and 27 November 2020, 2582 patients were randomly allocated to receive azithromycin and 5182 patients to receive usual care alone. Overall, 496 (19%) patients allocated to azithromycin and 997 (19%) patients allocated to usual care died within 28 days (rate ratio 1.00; 95% confidence interval [CI] 0.90-1.12; p=0.99). Consistent results were seen in all pre-specified subgroups of patients. There was no difference in duration of hospitalisation (median 12 days vs. 13 days) or the proportion of patients discharged from hospital alive within 28 days (60% vs. 59%; rate ratio 1.03; 95% CI 0.97-1.10; p=0.29). Among those not on invasive mechanical ventilation at baseline, there was no difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0.97; 95% CI 0.89-1.07; p=0.54). Interpretation: In patients hospitalised with COVID-19, azithromycin did not provide any clinical benefit. Azithromycin use in patients hospitalised with COVID-19 should be restricted to patients where there is a clear antimicrobial indication.

scholarly journals A multi centre randomized open label trial of chloroquine for the treatment of adults with SARS-CoV-2 infection in Vietnam

2020 ◽  
Vol 5 ◽  
pp. 141
Author(s):  
Evelyne Kestelyn ◽  
Nguyen Thi Phuong Dung ◽  
Yen Lam Minh ◽  
Le Manh Hung ◽  
Nguyen Minh Quan ◽  
...  
Keyword(s):  
Low Cost ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Rapid Decline ◽  
Tolerability Profile ◽  
Open Label ◽  
Field Hospital ◽  
Novel Coronavirus ◽  
Randomised Controlled ◽  
Evidence Based Guidelines

Background: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19. We hypothesise that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid decline of viral load in throat/nose swabs. This viral attenuation should be associated with improved patient outcomes. Method: The study will start with a 10-patient prospective observational pilot study following the same entry and exclusion criteria as for the randomized trial and undergoing the same procedures. The main study is an open label, randomised, controlled trial with two parallel arms of standard of care (control arm) versus standard of care with 10 days of chloroquine (intervention arm) with a loading dose over the first 24 hours, followed by 300mg base orally once daily for nine days. The study will recruit patients in three sites in Ho Chi Minh City, Vietnam: the Hospital for Tropical Diseases, the Cu Chi Field Hospital, and the Can Gio COVID hospital. The primary endpoint is the time to viral clearance from throat/nose swab, defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs. Viral presence will be determined using RT-PCR to detect SARS-CoV-2 RNA. Discussion: The results of the study will add to the evidence-based guidelines for management of COVID-19. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. Trial registration: Clinicaltrials.gov NCT04328493 31/03/2020

scholarly journals Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

2021 ◽  
Author(s):  
Peter W Horby ◽  
Mark Campbell ◽  
Enti Spata ◽  
Jonathan R Emberson ◽  
Natalie Staplin ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Rate Ratio ◽  
Invasive Mechanical Ventilation ◽  
Composite Endpoint ◽  
Standard Of Care ◽  
Open Label ◽  
Significant Difference ◽  
Randomised Controlled ◽  
To Receive

Background: Colchicine has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory actions. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus colchicine twice daily for 10 days or until discharge (or one of the other treatment arms) using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 27 November 2020 and 4 March 2021, 5610 patients were randomly allocated to receive colchicine and 5730 patients to receive usual care alone. Overall, 1173 (21%) patients allocated to colchicine and 1190 (21%) patients allocated to usual care died within 28 days (rate ratio 1.01; 95% confidence interval [CI] 0.93-1.10; p=0.77). Consistent results were seen in all pre-specified subgroups of patients. There was no significant difference in duration of hospitalisation (median 10 days vs. 10 days) or the proportion of patients discharged from hospital alive within 28 days (70% vs. 70%; rate ratio 0.98; 95% CI 0.94-1.03; p=0.44). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (25% vs. 25%; risk ratio 1.02; 95% CI 0.96-1.09; p=0.47). Interpretation: In adults hospitalised with COVID-19, colchicine was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.

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