|
| S. no. | Trial registration number | Author, country | Title | Study duration in days | Study arm | Intervention group | Control group | Concomitant drugs | Outcome measures | Outcome measures applicable to this review |
|
| 1 | NCT04353336 | Abd-Elsalam et al., Egypt | Hydroxychloroquine in the treatment of COVID-19: A multicenter randomized controlled study | 122 | 2 | Hydroxychloroquine | (i) Paracetamol
(ii) Oxygen
(iii) Fluids
(iv) Empiric antibiotic (cephalosporins)
(v) Oseltamivir
(vi) Invasive mechanical ventilation with hydrocortisone | — | (i) Death
(ii) Duration of hospital stay | (i) Death
(ii) Duration of hospital stay |
| 2 | Trial registration not specified. | Antinori et al., Italy | Compassionate remdesivir treatment of severe COVID-19 pneumonia in intensive care unit (ICU) and non-ICU patients: clinical outcome and differences in posttreatment hospitalization status | 27 | 1 | Remdesivir (ICU and ward setting) | None | — | (i) WHO ordinal scale
(ii) Hospitalization status
(iii) Adverse events | (i) WHO ordinal scale
(ii) Hospitalization status
(iii) Adverse events |
| 3 | NCT04323527 | Borba et al., Brazil | Effect of high vs. low doses of chloroquine diphosphate as adjunctive therapy for patients hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection | — | 2 | High-dose chloroquine (600 mg CQ; 4 × 150 mg tablets twice daily for 10 days; total dose 12 g) | Low-dose chloroquine (450 mg CQ twice daily on the first day and 450 mg once daily for 4 days) | (i) Intravenous ceftriaxone (1 g twice daily for 7 days)
(ii) Azithromycin (500 mg once daily for 5 days)
(iii) Oseltamivir (75 mg twice daily for 5 days) | (i) Safety
(ii) Lethality
(iii) Clinical status
(iv) Laboratory examinations
(v) Electrocardiogram results | (i) Safety
(ii) Lethality
(iii) Clinical status |
| 4 | ChiCTR2000029308 | Cao et al., China | A trial of lopinavir-ritonavir in adults hospitalized with severe COVID-19 | 17 | 2 | Lopinavir-ritonavir (400 mg and 100 mg twice daily) | (i) Supplemental oxygen
(ii) Noninvasive ventilation
(iii) Invasive ventilation
(iv) Antibiotic agents
(v) Vasopressor support
(vi) Renal replacement therapy
(vii) Extracorporeal membrane oxygenation (ECMO) | — | (i) WHO ordinal scale
(ii) Time to clinical improvement
(iii) Day 28 mortality
(iv) ICU length of stay | (i) WHO ordinal scale
(ii) Time to clinical improvement
(iii) Day 28 mortality
(iv) ICU length of stay |
| 5 | IRCT20200501047259N1 | Gharebaghi et al., Iran | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomized placebo-controlled double-blind clinical trial | — | 2 | Intravenous immunoglobulin (IVIG). Four vials of 5 g IVIG daily | Placebo and standard of care | — | Mortality | Mortality |
| 6 | NCT04383535 | Simonovich et al., Italy | A randomized trial of convalescent plasma in COVID-19 severe pneumonia | — | 2 | Convalescent plasma | Placebo and standard of care | (i) Antiviral agents
(ii) Glucocorticoids | (i) WHO ordinal scale
(ii) Clinical status at 30 days
(iii) 30 days mortality | (i) WHO ordinal scale
(ii) Clinical status at 30 days
(iii) 30 days mortality |
| 7 | NCT04375098 | Balcells et al., Chile | Early anti-SARS-CoV-2 convalescent Plasma in patients admitted for COVID-19: A randomized phase II clinical trial | 70 | 2 | Early plasma, 400 ml of ABO compatible convalescent plasma | Deferred plasma, 400 ml plasma | (i) Steroids
(ii) Tocilizumab
(iii) Hydroxychloroquine
(iv) Lopinavir/ritonavir
(v) Thromboprophylaxis
(vi) Anticoagulation | (i) Mechanical ventilation
(ii) Hospitalization >14 days
(iii) Death
(iv) Oxygen requirement | (i) Mechanical ventilation
(ii) Hospitalization >14 days
(iii) Death
(iv) Oxygen requirement |
| 8 | IRCT20150303021315N17 | Malekzadeh et al.,
Iran | Subcutaneous tocilizumab in adults with severe and critical COVID-19: A prospective open-label uncontrolled multicenter trial | 100 | 1 | Tocilizumab at a dose of 324 mg | (i) Antiviral agents
(ii) Hydroxychloroquine
(iii) Interferon beta-1a
(iv) Antibiotic agents | — | (i) Hospital Stay
(ii) Death
(iii) Oxygen requirement
(iv) Adverse events | (i) Hospital stay
(ii) Death
(iii) Oxygen requirement
(iv) Adverse events |
| 9 | NCT04346355 | Salvarani et al., Italy | Effect of tocilizumab vs. standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: A randomized clinical trial | 73 | 2 | Tocilizumab at a dose of 8 mg/kg up to a maximum of 800 mg | (i) Tocilizumab IV + steroids
(ii) Steroids
(iii) Canakinumab | (i) Hydroxychloroquine
(ii) Heparin
(iii) LMWH
(iv) Antiretroviral
(v) azithromycin | (i) Clinical worsening
(ii) At 14 days: admissions to ICU
(iii) At 14 days: deaths
(iv) At 14 days: discharges
(v) At 30 days: admissions to ICU
(vi) At 30 days: deaths
(vii) At 30 days: discharges | (i) Clinical worsening
(ii) At 14 days: admissions to ICU
(iii) At 14 days: deaths
(iv) At 14 days: discharges
(v) At 30 days: Admissions to ICU
(vi) At 30 days: deaths
(vii) At 30 days: discharges |
| 10 | NCT04356937 | Stone et al., the United States | Efficacy of tocilizumab in patients hospitalized with COVID-19 | 57 | 2 | Tocilizumab, 8 mg per kilogram of bodyweight administered intravenously, not to exceed 800 mg | Placebo and standard of care | (i) Remdesivir
(ii) Dexamethasone
(iii) Hydroxychloroquine
(iv) Glucocorticoids | (i) Death
(ii) Intubation
(iii) Oxygen requirement | (i) Death
(ii) Intubation
(iii) Oxygen requirement |
| 11 | NCT04257656 | Wang et al., China | Remdesivir in adults with severe COVID-19: a randomized, double-blind, placebo-controlled, multicenter trial | 36 | 2 | Remdesivir, 200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions | Placebo and standard of care | (i) Lopinavir-ritonavir
(ii) Interferons
(iii) Corticosteroids | (i) Time to clinical improvement within 28 days
(ii) Mortality at day 28
(iii) Safety outcomes included treatment-emergent adverse events, serious adverse events, and premature discontinuation of study drugs. | (i) Time to clinical improvement within 28 days
(ii) Mortality at day 28
(iii) Safety outcomes included treatment-emergent adverse events, serious adverse events, and premature discontinuation of study drugs. |
| 12 | NCT04405843 | Medina et al., Colombia | Effect of ivermectin on time to resolution of symptoms among adults with mild COVID-19: A randomized clinical Trial | 17 | 2 | Ivermectin and standard of care: received 300 μg/kg | Placebo and standard of care | (i) NSAIDS
(ii) Macrolides
(iii) Antipyretics
(iv) Antibiotics
(v) Glucocorticoids
(vi) Immunomodulating
(vii) Anticoagulants | (i) Deaths
(ii) Clinical deterioration
(iii) Adverse events | (i) WHO ordinal scale
(ii) Deaths
(iii) Clinical deterioration
(iv) Adverse events |
| 13 | NCT04276688 | Hung et al., Hong Kong | Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: An open-label, randomized, phase 2 trial | 40 | 2 arms | (i) Interferon beta-1b
(ii) Lopinavir-ritonavir
(iii) Ribavirin | Lopinavir-ritonavir | — | (i) Mortality
(ii) Length of hospital stay
(iii) Negative RT-PCR result | (i) Mortality
(ii) Length of hospital stay
(iii) Negative RT-PCR result |
| 14 | ChiCTR2000029387 | Huang et al., China | No statistically apparent difference in antiviral effectiveness observed among ribavirin plus interferon-alpha, lopinavir/ritonavir plus interferon-alpha, and ribavirin plus lopinavir/ritonavir plus interferon-alpha in patients with mild-to-moderate coronavirus disease 2019: results of a randomized, open-labelled prospective study | 28 | 3 | (i) Ribavirin
(ii) Lopinavir/ritonavir
(iii) Interferon-alpha | — | — | (i) Death
(ii) Length of hospitalization
(iii) Negative SARS-CoV-2 results
(iv) Adverse events | (i) Death
(ii) Length of hospitalization
(iii) Negative SARS-CoV-2 results
(iv) adverse events |
| 15 | NCT04292899 | Olender et al., multicenter | Remdesivir for severe coronavirus disease 2019 (COVID-19) versus a cohort receiving standard of care | 33 | 2 | Remdesivir | No remdesivir | (i) Azithromycin
(ii) Hydroxychloroquine
(iii) HIV protease inhibitor
(iv) Biologics
(v) Ribavirin | (i) WHO ordinal score
(ii) Recovery on day 14
(iii) Death at day 14
(iv) Clinical improvement on day 14 | (i) WHO ordinal score
(ii) Recovery on day 14
(iii) Death at day 14
(iv) Clinical improvement on day 14 |
| 16 | ChiCTR2000029757 | Li et al., China | Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: A randomized clinical trial | 48 | 2 | Convalescent plasma | Standard of care | (i) Antiviral
(ii) Antibacterial
(iii) Steroids
(iv) Human immunoglobulin | (i) WHO ordinal scale
(ii) Time to clinical improvement
(iii) Discharge rate at 28 days
(iv) Mortality at 28 days
(v) Negative PCR | (i) WHO ordinal scale
(ii) Time to clinical improvement
(iii) Discharge rate at 28 days
(iv) Mortality at 28 days
(v) Negative PCR |
| 17 | NCT 04321421 | Perotti et al., Italy | Mortality reduction in 46 severe COVID-19 patients treated with hyperimmune plasma: A proof-of-concept single arm multicenter interventional trial | 32 | 1 | Plasma infusion | None | (i) Antiviral
(ii) Antibiotics
(iii) Hydroxychloroquine
(iv) Anticoagulant | (i) Mortality
(ii) Changes in PaO2/FiO2, LDH | (i) Mortality
(ii) Oxygen requirement |
| 18 | NCT04292730 | Spinner et al., multicenter | Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: A randomized clinical trial | 35 | 3 | 10 days remdesivir | (i) 5 days remdesivir
(ii) Standard of care | (i) Steroids
(ii) Hydroxychloroquine/chloroquine
(iii) Lopinavir-ritonavir
(iv) Tocilizumab
(v) Azithromycin | (i) Death
(ii) Discharge
(iii) Adverse events | (i) Death
(ii) Discharge
(iii) Adverse events |
| 19 | CTRI/2020/04/024775 | Agarwal et al., India | Convalescent plasma in the management of moderate COVID-19 in adults in India: open-label phase II multicenter randomized controlled trial (PLACID trial) | 84 | 2 | Convalescent plasma (two doses of 200 ml) + best standard of care. | Standard of care | (i) Hydroxychloroquine
(ii) Remdesivir
(iii) Lopinavir
(iv) Ritonavir
(v) Oseltamivir
(vi) Antibiotics
(vii) Steroids
(viii) Tocilizumab | (i) Mortality
(ii) Clinical improvement on the World Health Organization ordinal scale | (i) Mortality
(ii) Clinical improvement on the World Health Organization ordinal scale |
|
