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