Early treatment with inhaled GM-CSF improves oxygenation and anti-viral immunity in COVID-19 induced lung injury – a randomized clinical trial

Abstract Granulocyte-macrophage colony-stimulating factor (GM-CSF) instructs monocytes to differentiate into alveolar macrophages (AM) that preserve lung homeostasis. By comparing AM development in mouse and human, we discovered that COVID-19 patients showed marked defects in GM-CSF-dependent AM instruction. The multi-center, open-label, randomized, controlled SARPAC-trial evaluated the efficacy and safety of 5 days of inhalation of rhu-GM-CSF (sargramostim, Leukine®) in 81 non-ventilated patients with COVID-19 and hypoxemic respiratory failure identified by PaO2/FiO2 ratio < 350mmHg. At day 6, more patients in the sargramostim group experienced at least 25% improvement in oxygenation compared with the standard of care group. Higher numbers of circulating class-switched B cells and effector virus-specific CD8 lymphocytes were found in the sargramostim group. Treatment adverse events, including signs of cytokine storm, were not different between active and control group. This proof-of-concept study demonstrates the feasibility and safety of inhaled GM-CSF in restoring alveolar gas exchange, while simultaneously boosting anti-COVID-19 immunity. ClinicalTrials.gov (NCT04326920).

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Antibiotics in children with bronchial asthma

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20171560 ◽

2017 ◽

Vol 4 (3) ◽

pp. 843 ◽

Cited By ~ 1

Author(s):

Safal Muhammed ◽

Deepak Joshi

Keyword(s):

Bronchial Asthma ◽

Standard Of Care ◽

Care Group ◽

Control Group ◽

P Value ◽

Acute Exacerbations ◽

Acute Asthma Exacerbation ◽

Antibiotic Group ◽

Empirical Antibiotics ◽

And Control

Background: This study was conducted to determine if oral antibiotics started at presentation reduce the duration of acute exacerbations of bronchial asthma by comparing the durations of mild to moderate exacerbations of asthma managed with or without antibiotics in children below 12 years.Methods:In this systematic trial, we allocated the eligible children to antibiotic group (who also received standard of care and control (the standard of care) group (n=40 in each group) and compared the duration of acute asthma exacerbation between the two groups.Results: The mean difference of duration of mild and moderate exacerbations between the antibiotic and control group was 4.76 hours (95% Confidence Interval (CI) of -36.76 to 28.84) which was found not to be statistically significant (p value- 0.482).Conclusions:There was no significant reduction in the duration of mild to moderate exacerbations of asthma in children below 12 years by the administration of empirical antibiotics.

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Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa241 ◽

2020 ◽

Vol 7 (7) ◽

Cited By ~ 13

Author(s):

Jun Chen ◽

Lu Xia ◽

Li Liu ◽

Qingnian Xu ◽

Yun Ling ◽

...

Keyword(s):

Antiviral Activity ◽

Interferon Alpha ◽

Clearance Rate ◽

Standard Of Care ◽

Study Groups ◽

Control Group ◽

Open Label ◽

Intention To Treat ◽

Interferon Alpha 2B ◽

And Control

Abstract Background We aimed to evaluate the antiviral activity and safety of darunavir/cobicistat (DRV/c) in treating COVID-19 patients. Methods In this single-center, randomized, and open-label trial, mild patients with polymerase chain reaction (PCR)–confirmed COVID-19 were enrolled in Shanghai, China. Participants were randomized to receive DRV/c for 5 days on the top of interferon alpha 2b inhaling or interferon alpha 2b inhaling alone. The primary end point was the virological clearance rate of oropharyngeal swabs at day 7 after randomization in the intention-to-treat population (clinicaltrials.gov: NCT04252274). Results From January 30, 2020, to February 6, 2020, a total of 30 patients were enrolled, of whom 18 (60%) were male, aged 47.2 ± 2.8 years; 63.3% (19/30) of the participants had fever, and 46.7% (14/30) had cough at enrollment. The participants were randomized (range) at 4 (2–5) days after onset of symptoms. The proportion of negative PCR results at day 7 was 46.7% (7/15) and 60.0% (9/15) in the DRV/c and control groups (P = .72), respectively. The viral clearance rate at day 3 was 20% (3/15) in both study groups, while the number increased to 26.7% (4/15) in the DRV/c group and remained 20% (3/15) in the control group at day 5. Fourteen days after randomization, 1 participant in the DRV/c group progressed to critical illness and discontinued DRV/c, while all the patients in the control group were stable (P = 1.0). The frequencies of adverse events in the 2 groups were comparable. Conclusions Five days of DRV/c did not increase the proportion of negative conversion vs standard of care alone, although it was well tolerated.

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A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19)

PLoS ONE ◽

10.1371/journal.pone.0242763 ◽

2020 ◽

Vol 15 (12) ◽

pp. e0242763 ◽

Cited By ~ 1

Author(s):

Cheng-Pin Chen ◽

Yi-Chun Lin ◽

Tsung-Chia Chen ◽

Ting-Yu Tseng ◽

Hon-Lai Wong ◽

...

Keyword(s):

Retrospective Study ◽

Controlled Trial ◽

Standard Of Care ◽

Public Hospitals ◽

Control Group ◽

Rt Pcr ◽

Open Label ◽

Viral Shedding ◽

Randomized Controlled ◽

And Control

Objective In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study. Methods Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020. Results There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70). Conclusions Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.

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Perbandingan Efek Suplementasi Tablet Tambah Darah Dengan Dan Tanpa Vitamin C Terhadap Kadar Hemoglobin Pada Ibu Hamil Dengan Usiakehamilan 16-32 Minggu Di Desa Keniten Kecamatan Mojo Kabupaten Kediri

Jurnal Ilmu Kesehatan ◽

10.32831/jik.v3i1.49 ◽

2017 ◽

Vol 3 (1) ◽

pp. 76

Author(s):

Siti Asiyah ◽

Dwi Estuning Rahayu ◽

Wiranti Dwi Novita Isnaeni

Keyword(s):

Treatment Group ◽

Vitamin C ◽

Gestational Age ◽

Group Treatment ◽

Sampling Technique ◽

Hemoglobin Level ◽

The Body ◽

Control Group ◽

Fetal Organ ◽

And Control

The needed of Iron Tablet in pregnancy was increase than mother who not pregnant. That cause of high metabolism at the pregnancy for formed of fetal organ and energy. One of effort for prevent anemia in mother pregnant with giving the Iron tablet and vitamin c. The reason of this research in 4 June – 11 July 2014 is for compare the effect of iron tablet suplementation with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks In Desa Keniten Kecamatan Mojo Kabupaten Kediri. This research method using comparative analytical. Research design type of Quasy Eksperiment that have treatment group and control group. Treatment group will giving by Iron tablet and 100 mg vitamin C, and control group just giving by iron tablet during 21 days. Population in this research are all of mother pregnant with Gestational Age Of 16-32 Weeks with Sampling technique is cluster random sampling is 29 mother pregnant. Comparison analysis of iron tablet suplementation effect with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks, data analysis using Mann Whitney U-test and the calculated U value (44,5) less than U-table (51). So there was difference of iron tablet suplementation effect with and without vitamin C toward Hemoglobin level in mother pregnant With Gestational Age Of 16-32 Weeks Therefore, the addition of vitamin C on iron intake is needed to increase the uptake of iron tablets. When the amount of iron uptake increases, the reserves of iron in the body will also increase, so as to prevent anemia in pregnant women; Keywords : Iron Tablet (Fe), Vitamin C, Hemoglobin level, Mother Pregnant

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Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

Tropical Doctor ◽

10.1177/0049475520984745 ◽

2021 ◽

pp. 004947552098474

Author(s):

Arjuman Sharmin ◽

Ali Hossain ◽

Nazmul Islam ◽

Zakir H Sarker ◽

Sheikh S Hossain ◽

...

Keyword(s):

Clinical Trial ◽

Lymph Node ◽

Complete Resolution ◽

Conventional Treatment ◽

Symptomatic Improvement ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Lymph Node Tuberculosis ◽

And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

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Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

10.1101/2020.08.26.20182444 ◽

2020 ◽

Cited By ~ 7

Author(s):

Cristina Avendano-Sola ◽

Antonio Ramos-Martinez ◽

Elena Munez-Rubio ◽

Belen Ruiz-Antoran ◽

Rosa Malo de Molina ◽

...

Keyword(s):

Clinical Trial ◽

Mechanical Ventilation ◽

Randomized Clinical Trial ◽

Strong Dependence ◽

Standard Of Care ◽

Ordinal Scale ◽

Control Group ◽

Standard Of Care Treatment ◽

And Control ◽

To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

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A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of Herbovir syrup in mildly symptomatic COVID-19 patients

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20205548 ◽

2020 ◽

Vol 10 (1) ◽

pp. 106

Author(s):

A. Gopal Rao ◽

Shankar Achar Somashekar ◽

Poorna Prasad ◽

Manjunath Reddy Lekkala ◽

Sreenivasa Hanumanthaiah ◽

...

Keyword(s):

Clinical Symptoms ◽

Standard Of Care ◽

Pulmonary Complications ◽

Controlled Study ◽

Control Group ◽

P Value ◽

Immune Markers ◽

Open Label ◽

Early Recovery ◽

D Dimer

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications. Effective antiviral and immune boosters are need of hour to treat COVID-19 as well as post COVID complications.Methods: In this study involving mild COVID-19 we randomized 40 patients to receive a Herbovir syrup along with standard of care (SOC) or SOC alone in 1:1 ratio. We evaluated the benefits of Herbovir syrup by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer).Results: At the end of the study the immune markers in Herbovir group improved significant compared to control group. In patients who received Herbovir, LDH decreased from 334 U/l at baseline to 254 U/l at the end of treatment (p value <0.009), CRP decreased from 7.4 mg/l to 3.1 mg/l (p value=0.0171) and D-dimer decreased from 0.610 mg/l at baseline to 318 mg/l at the end of study (p value=0.001). TLC values did not go below normal range in Herbovir group whereas 8 patients in control group had low TLC at the end of study. Early recovery from COVID 19 symptoms was observed in >75% patients in Herbovir treated group.Conclusions: Herbovir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that Herbovir syrup has antiviral, immune booster activity and has definitive role in the management of mild COVID-19 patients along with standard of care. (Funded by Venkat pharma. CTRI no. CTRI/2020/08/027041).

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Pengaruh Pendidikan Kesehatan Metode Brainstorming dan Video terhadap Pengetahuan tentang Demam Berdarah pada Keluarga di Wilayah Kerja Puskesmas Puger Kabupaten Jember (The effect of Health Education Brainstorming Method and Video to the Knowledge about

Pustaka Kesehatan ◽

10.19184/pk.v6i1.6869 ◽

2018 ◽

Vol 6 (1) ◽

pp. 141 ◽

Cited By ~ 1

Author(s):

Mukhammad Syafi`udin ◽

Wantiyah Wantiyah ◽

Kushariyadi Kushariyadi

Keyword(s):

Treatment Group ◽

Health Education ◽

Dengue Fever ◽

Dengue Hemorrhagic Fever ◽

Group Treatment ◽

Hemorrhagic Fever ◽

Simple Random Sampling ◽

T Test ◽

Control Group ◽

And Control

The increasing cases of dengue hemorrhagic fever disease in both children and adults can beinfluenced by several factors. One of that influences increasing of dengue fever is lack of communityknowledge about dengue hemorrhagic fever. Brainstorming is a form of discussion to gather theinformation from all participants. This research was to find out the effect of health educationbrainstorming method and video toward knowledge of dengue fever in the work area of Puger PublicHealth Center the distric of Jember. This was a quasy experiment research with two groups pretestposttesttreatment design. The population were 88 families with 30 respondents as sample,conducted by simple random sampling, and divided into two groups 15 respondents as treatmentgroup and 15 respondents as control group. Treatment group got health education brainstormingmethod combined with video and control group got health education brace method. Data wereanalyzed used t-test dependent and t-test independent with 95% CI (α: 0,05). The result showedthere were significant differences of knowledge before and after in both treatment group and controlgroup (p: 0,000) and there were significant differences between treatment group and control afterhealth education (p: 0,001). Overall, health education by brainstorming method and can improveknowledge of dengue hemorrhagic fever. It is recommended for nurses to do health educationpreventation and treatment about dengue hemorrhagic fever to improve knowledge people.Keywords: health education brainstorming method and video, knowledge, dengue hemorrhagicfever

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Preventive efficacy of Grippol® plus in children aged 8 to 14 years residing in Almaty (Republic of Kazakhstan)

Voprosy praktičeskoj pediatrii ◽

10.20953/1817-7646-2020-6-27-34 ◽

2020 ◽

Vol 15 (6) ◽

pp. 27-34

Author(s):

L.T. Yeraliyeva ◽

◽

Zh.N. Suleymenova ◽

M.A. Smagul ◽

M.K. Smagulova ◽

...

Keyword(s):

Viral Infections ◽

Control Group ◽

Open Label ◽

Active Monitoring ◽

Preventive Efficacy ◽

Efficacy Index ◽

Respiratory Viral Infections ◽

Study Participants ◽

And Control ◽

Experimental Group

Objective. To evaluate preventive efficacy and reactogenicity of Grippol® plus vaccine in children aged 8 to 14 years residing in Almaty (Republic of Kazakhstan). Patients and methods. This open-label prospective study was conducted between October 2019 and April 2020 and included 600 children aged 8 to 14 years (mean age 10.6 ± 4.9 years) studying in two schools of Almaty. Study participants were divided into two groups (300 children in each): experimental group, in which children were vaccinated with Grippol® plus (Petrovax Pharm, Russia) in accordance with all rules and control group. Patients in both groups were matched for gender; children of the Mongoloid race prevailed in the experimental group. Parents (or official representatives) of all participants signed an informed consent before the enrollment. The efficacy of vaccination was evaluated by active monitoring (telephone contacts with parents) and assessment of the incidence of influenza and acute respiratory viral infections (ARVIs) during the next 6 months. We calculated the efficacy index and efficacy coefficient. Data analysis was performed using the Statistica 6.0 software; differences were considered significant at p < 0.05. Results. Follow-up of study participants during 6 months after vaccination demonstrated significant differences in the incidence of ARVIs and influenza between the two groups: 7 cases among vaccinated children (2,3%) vs 21 cases among controls (7%) (p < 0.05). One child from the control group had two episodes of ARVI. Mean duration of influenza and ARVIs in the experimental group was 1.8 times lower than that in the control group. The efficacy index and efficacy coefficient, calculated with the consideration of influenza diagnosis confirmation by polymerase chain reaction, were 3% and 66.7%, respectively. Local and systemic reactions to vaccination were observed in 3 children, were transient, and disappeared after 2–3 days. Conclusion. The trivalent inactivated polymer-subunit vaccine Grippol® plus was safe and effective in children aged between 8 and 14 years. Key words: vaccine, influenza, children, incidence, acute respiratory viral infections, efficacy

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Treatment of Skin Injury due to Vinorelbine Extravasation Using bFGF and rhGM-CSF: An Experimental Study in a Murine Model

Biological Research For Nursing ◽

10.1177/1099800410378160 ◽

2010 ◽

Vol 13 (1) ◽

pp. 32-37 ◽

Cited By ~ 3

Author(s):

Chunhua Yu ◽

Jin Wang ◽

Yan Fu ◽

Yongqiu Mao ◽

Yongshun Chen ◽

...

Keyword(s):

Murine Model ◽

Maximum Size ◽

Experimental Models ◽

Control Group ◽

Skin Injury ◽

Macrophage Colony Stimulating Factor ◽

The Difference ◽

Macrophage Colony ◽

And Control

Background and objective: A murine model of skin injury from vinorelbine extravasation was established to evaluate the treatment efficacy of basic fibroblast growth factor (bFGF) and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF). Materials and method: Experimental models were divided into bFGF, rhGM-CSF, and control (saline) groups, with 40 mice in each group. Edema and ulceration were measured on Days 1, 3, 5, 7, 10, 14, and 18 after the onset of extravasation; injuries were examined pathomorphologically in three mice/group/time point. Results: Edema reached maximum size on Day 3 in the bFGF and rhGM-CSF groups and Day 5 in the control group. The difference between the two experimental groups was not significant; differences between the control group and the experimental groups were statistically significant at all time points. Edema and ulceration began to improve on Day 10 in the bFGF and rhGM-CSF groups and Day 18 in the control group. Healing duration was 14—18 days in the experimental groups, with a (not significantly) shorter duration in the bFGF group. Healing was completed by Day 27.5 in the control group. Pathomorphological evaluation showed regular reepithelization and newly formed granulation tissue in the bFGF and rhGM-CSF groups on Day 13. In the control group, wounds were partially healed, edema and shallow ulcers existed, and epithelization was fragile and disorganized on Day 18. Conclusions: bFGF and rhGM-CSF are useful for the treatment of skin injury due to vinorelbine extravasation, but bFGF may be slightly more effective in decreasing time and improving quality of healing.

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