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. 2021 Jun 18;61:2–15. doi: 10.1016/j.cytogfr.2021.06.002

Table 2.

Characteristics of the clinical trials performed on COVID-19 patientsa.

Agent Clinical trials Objective Intervention Control Primary outcome measures
Melatonin TrialTroveID-375830 To evaluate the therapeutic effects of melatonin by inhibition of NLRP3 inflammasome in COVID-19 patients 9 mg melatonin for 7–10 nights The usual treatment The amount of melatonin [Time Frame: Up to 10 days]
Statins TrialTroveID-379443 To study safety and efficacy of the combination of colchicine and rosuvastatin in addition to standard of care in hospitalized patients with SARS-CoV-2 40 mg rosuvastatin daily and 0.6 mg colchicine twice for 3 days and then 0.6 mg daily The standard care COVID-19 severity (as defined by World Health Organization Ordinal Scale) [Time Frame: 30 Days]
IFN TrialTroveID-371689 To investigate the beneficial effects of IFNβ-1a, compared to IFNβ-1b and the base therapeutic regiment in moderate to severe COVID-19 44 μg IFNβ-1a on days 1, 3, 6 (for Arm1);
0.25 mg IFNβ-1b on days 1, 3, 6 (for Arm2);
400 mg hydroxychloroquine on day 1 + 400 mg lopinavir/100 mg ritonavir twice a day for 10 days (for Arm1,2)
400 mg hydroxychloroquine on day 1 + 400 mg lopinavir/100 mg ritonavir twice a day for 10 days Time to clinical improvement [Time Frame: From date of randomization until 14 days later]
TrialTroveID-370679 To evaluate the efficacy and safety of IFNβ-1b in the treatment of COVID-19 250 μg IFNβ-1b subcutaneously every other day for 14 days Hydroxychloroquine + lopinavir/ritonavir for at least 5 days Response to the treatment daily;
Complications of the treatment daily
TrialTroveID-392370 To test whether IFNα-2b can provide additional benefit to these patients in terms of reduced rate of hospitalization and better time to recovery Single dose of 1 μg/kg pegylated IFNα-2b The standard care Change in ordinal scale [Time Frame: From baseline to day 11]
TrialTroveID-372573 To evaluate peginterferonλ in ambulatory and hospitalized patients with mild to moderate COVID-19 180 μg peginterferonλ-1a at baseline and a second dose on day 7 Placebo Proportion swab negative [Time Frame: At day 7];
Treatment-emergent and treatment related serious adverse events [Time Frame: Day 0 to day 30];
Time to viral negativity [Time Frame: Day 0 to day 28]
Sirolimus TrialTroveID-378925 To illustrate the efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol against COVID-19 infection 6 mg sirolimus daily on day 1 followed by 2 mg daily for 9 days The standard care Time to clinical recovery [Time Frame: 14−28 days];
Viral clearance [Time Frame: 14 days]
TrialTroveID-371558 To determine if treatment with sirolimus can improve clinical outcomes in hospitalized patients with COVID-19 6 mg sirolimus daily on day 1 followed by 2 mg daily for the next 13 days Placebo Proportion of patients who are alive and free from advanced respiratory support measures at day 28 [Time Frame: 28 days]
TrialTroveID-373755 To study the effect of hydroxychloroquine in combination with azithromycin or sirolimus for treating COVID-19 patients 250 mg azithromycin daily for 10 days (for Arm1);
4 mg sirolimus for 1 day then 2 mg daily for 9 days (for Arm2);
600 mg hydroxychloroquine daily for 10 days (for Arm1,2)
None Time to clinical improvement
Azithromycin TrialTroveID-390593 To assess the clinical effectiveness and safety profile of the COVID-19 treatment protocol (containing both hydroxychloroquine and azithromycin) in an Iraqi specialized hospital 500 mg azithromycin on day 1, then 250 mg daily for 5 days + 400 mg hydroxychloro twice a day on day 1 then 200 mg twice a day for 5 days (for Arm1,2,3);
75 mg tamiflu twice a day for 5 days (for Arm2,3);
200 mg lopinavir/ 50 mg ritonavir twice a day for 5 days and antibiotic(s) accordingly (for Arm3)
None The changes in clinical and biochemical parameters during hospitalization period such as disappearance of clinical symptoms, virologic clearance and occurrence of side effects
Cyclosporine TrialTroveID-383935 To evaluate low doses of corticosteroids and cyclosporine combined with enoxaparin, in patients with COVID-19 pneumonia Cyclosporine A at a dose of 1−2 mg /kg / day divided into two doses, for 7 days The standard treatment: 0.5 mg/kg enoxaparin once, 500 mg clarithromycin twice and metylprednisolone 0.5 mg/kg once Number of days to clinical improvement until hospital discharge or death. [Time Frame: 28 days]
Colchicine TrialTroveID-381747 To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes 0.5 mg colchicine three times a day for 5 days, then 0.5 mg twice a day for 5 days (a loading dose of 1 mg if body weight ≥80 kg) Placebo Number of days of need of supplemental oxygen by catheter or masks;
Number of days from the admission to the discharge;
The percentage of individuals who will require admission to the intensive care unit;
The percentage of death
TrialTroveID-383970 To evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization 1.5 mg colchicine orally on day 1 (initial 1 mg and 0.5 mg at 2 h), then 0.5 mg every 12 h on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days The standard treatment Number of participants who die or require transfer to intensive care unit [Time Frame: In the first 15 days after randomization]
Baricitinib TrialTroveID-393453 To evaluate the efficacy of remdesivir and baricitinib combination therapy for the treatment of ARDS caused by COVID-19;
To compare the outcome of the "remdesivir + baricitinib" against "remdesivir + tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients
5 mg/kg (<40 kg) or 200 mg (>40 kg) remdesivir I/V on day 1, then 2.5 mg/kg (< 40 kg) or 100 mg (> 40 kg) daily following randomization (for Arm1,2);
4 mg baricitinib tablets daily for 2–4 weeks (for Arm1);
8 mg/kg tocilizumab I/V (up to 800 mg highest) 12 h apart (for Arm2)
None Time to clinical improvement [Time Frame: Following randomization 30 days]
TrialTroveID-376590 To evaluate the efficacy and safety of baricitinib in hospitalized adults with COVID-19 4 mg of baricitinib once daily Placebo Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation) [Time Frame: Day 1 to day 28]
Acalabrutinib TrialTroveID-374074 To investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with best supportive care in the treatment of COVID-19 100 mg acalabrutinib twice a day for 10 days Best supportive care Occurrence of adverse events and serious adverse events [Time Frame: Day 28];
Proportion of subject alive and free of respiratory failure [Time Frame: Day 28]
Anakinra TrialTroveID-387990 To determine the efficacy of anakinra, an IL-1 receptor blocker, in reducing the need for mechanical ventilation and/or 28-day mortality among patients with COVID-19 who have features of cytokine storm syndrome and severe respiratory failure Anakinra IV 4 times a day for 7 days (100 mg anakinra mixed with 100 ml of 0.9 % saline solution for IV administration) 0.9 % saline Number of subjects alive without having required mechanical ventilation [Time Frame: 28 days post randomization]
TrialTroveID-381687 To investigate whether anakinra may reduce the need for invasive mechanical ventilation and deaths when compared to standard of care in patients with severe COVID-19 100 mg anakinra once daily for 3 days, followed by 100 mg once every other day for 7 days The standard treatment Need for invasive mechanical ventilation or admission to the intensive care unit [Time Frame: From patient records between baseline and 14 days];
In-hospital mortality [Time Frame: From patient records between baseline and death or discharge]
Canakinumab TrialTroveID-394661 To evaluate canakinumab to improve respiratory function and laboratory parameters compared with standard therapy (hydroxycloroquine + lopinavir/ritonavir) 300 mg canakinumab by single subcutaneous administration Standard therapy: hydroxycloroqui + lopinavir/ritonavir /
Sarilumab TrialTroveID-374439 To generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in COVID-19 pneumonia Sarilumab prefilled syringe None Proportion of patients who show an improvement of the respiratory function [Time Frame: 6 weeks]
Tocilizumab TrialTroveID-395500 To analyze the effectiveness of tocilizumab in moderate to severe COVID-19 participants on the basis of predefined assessment criteria Tocilizumab 8 mg/kg (up to 800 mg/dose) over 1 h, followed by up to three additional doses if required as per the response after the first dose with 8 h intervals 80 mg methylprednisolne daily in two divided doses as per national/local guidelines Decreased mortality in participants [Time Frame: 30 days]; Hospital & intensive care unit stay in days [Time Frame: 14 days]
TrialTroveID-379637 To assess the effects of tocilizumab, an IL-6 receptor antagonist, on intra-hospital mortality and development of positive cultures in patients with COVID-19 admitted to the intensive care unit A single dose of 400 mg intravenous tocilizumab twice a day The standard care Intra-hospital mortality
Dornase alfa TrialTroveID-371650 To evaluate the efficacy and safety of aerosolized intra-tracheal dornase alfa administration in mechanically ventilated patients hospitalized for COVID-19-related ARDS 2500 IU dornase alfa inhalation solution twice daily, 12 h apart, for 7 consecutive days The usual care Efficacy of intra-tracheal administration [Time Frame: Day 7];
Improvement in the ARDS scale severity (Berlin criteria). [Time Frame: Day 7]
a

Characteristics of each clinical trial obtained from Citeline.informa.com.