Table 3.
Interventional trials on COVID-19 listed as completed on ClinicalTrials.gov.
| NCT Number | Title | Interventions | Phase | Allocation & masking | Enrollment no. (age) | Primary outcome measures | References |
|---|---|---|---|---|---|---|---|
| NCT04343768 | An Investigation Into Beneficial Effects of Interferon β-1a, Compared to Interferon β-1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial | Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β-1a VS HCQ + LPV /r + IF-β-1b VS Control group: HCQ + LPV/r |
Phase 4 | Randomized; Open Label | 60 (≥18) | Time to clinical improvement | [86] |
| NCT04244591 | Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial | Experimental: standard care + Methylprednisolone 40 mg q12h for 5 days VS Placebo Comparator: standard care |
Phase 2 Phase 3 |
Randomized; Open Label | 80 (≥18) | Lower Murray lung injury score | |
| NCT04291729 | Evaluation of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection | Experimental: Ganovo + ritonavir with or without interferon nebulization | Phase 4 | Single Group Assignment;Open Label | 11 (18 to 75 y/o) | Rate of composite adverse outcomes [ Time Frame: 14 days ] | |
| NCT04261517 | Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19 | Experimental: HCQ (400 mg per day for 5 days) and conventional treatments VS No Intervention: Conventional treatments |
Phase 3 | Randomized; Open Label | 30(≥18) | The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3, 5, and 7. The mortality rate of subjects at week 2 |
|
| NCT04359251 | Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study | Experimental: Optimizing oxygenation Best oxygenation during PEEP titration VS Experimental: Optimizing compliance Best compliance during PEEP titration VS Experimental: ARDSnet PEEP settings according to ARDSnet table |
Not Applicable | Non-Randomized; Open Label | 20 (18 to 80 y/o) | Respiratory system compliance improvement [ Time Frame: 20 min ] | |
| NCT04358614 | Baricitinib Therapy in COVID-19: A Pilot Study on Safety and Clinical Impact | Cases: Baricitinib Oral Tablet 4 MG /day VS Controls: Standard therapy. |
Phase 2 Phase 3 |
Non-Randomized; Open Label | 12 (>18 and <75) | To assess the safety of baricitinib combined with antiviral (lopinavir-ritonavir) in terms of serious or non-serious adverse events incidence rate. [ Time Frame: 2 weeks ] | |
| NCT04276688 | Lopinavir/ Ritonavir, Ribavirin and IFN-beta Combination for nCoV Treatment | Study group: LPV/r 400 mg/100 mg twice daily for 14 days + Ribavirin 400 mg twice daily for 14 days + IF β-1b 0.25 mg subcutaneous injection alternate day for 3 days VS Control group: LPV/r 400 mg/100 mg twice daily for 14 days |
Phase 2 | Randomized; Open Label | 127(≥18) | Time to negative nasopharyngeal swab (NPS) 2019-n-CoV coronavirus viral RT-PCR | |
| NCT04368377 | Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol | Experimental: 25 µg/kg of body weight tirofiban as bolus IV injection (3 min) followed by continuous infusion at a rate of 0.15 µg /kg/min for 48 h. Acetylsalicylic acid 250 mg IV before starting tirofiban, and this will be continued at a dose of 75 mg daily for 30 days. A loading dose of clopidogrel 300 mg PO, followed by 75 mg daily for 30 days. Concurrent fondaparinux 2.5 mg s/c per day for the duration of the hospital stay |
Phase 2 | Single Group Assignment;Open Label | 5(≥18) | P/F ratio; PaO2 difference; AND A-a O2 difference at baseline, 24, 48 and 168 h after treatment initiation |
|
| NCT04324489 | DAS181 for Severe COVID-19: Compassionate Use | Experimental: DAS181 Treatment Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days. |
Not Applicable | Single Group Assignment;Open Label | 4 (18 to 70 y/o) | Improved clinical status [ Time Frame: Day 14 ] AND Return to room air [ Time Frame: Day 14 ] |
|
| NCT04321421 | Hyperimmune Plasma for Critical Patients With COVID-19 (COV19-PLASMA) | Experimental: administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5 | Not Applicable | Single Group Assignment;Open Label | 49(≥18) | Death [ Time Frame: within 7 days ] | |
| NCT04273321 | Efficacy and Safety of Corticosteroids in COVID-19 | Experimental: Methylprednisolone 1 mg/kg/day ivgtt for 7 days | Not Applicable | Single Group Assignment;Open Label | 86(≥18) | The incidence of treatment failure in 14 days [ Time Frame: 14 days ] | |
| NCT04378712 | Hydrogen/Oxygen Mixed Gas Inhalation for Coronavirus Disease 2019 (COVID-19) | Experimental: Intervention Group Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge. Control Group: Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission |
Not Applicable | Non-Randomized; Open Label | 90 (18 to 75 y/o) | Proportion of patients with improved disease severity at day 2 [ Time Frame: from baseline to day 2 ]; Proportion of patients with improved disease severity at day 3 [ Time Frame: from baseline to day 3 ]; AND Proportion of patients with improved disease severity at the day before hospital discharge [ Time Frame: up to 14 days (from baseline to the day before hospital discharge) ] |
|
| NCT04280705 | Adaptive COVID-19 Treatment Trial (ACTT) | Experimental: Remdesivir 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. n = 286. VS Placebo Comparator: Placebo |
Phase 3 | Randomized; Double-blind; Placebo-controlled | 1062 (18 to 99 y/o) | Time to recovery [ Time Frame: Day 1 through Day 29 ] | |
| NCT04304053 | Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention (HCQ4COV19) | Experimental: Testing, treatment and prophylaxis of SARS-CoV-2 Study 1 – Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14. Contacts will be offered a prophylactic regimen of hydroxychloroquine (200 mg tablets) 800 mg on day 1, and 400 mg on days 2–7. Study 2 – Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7. Cases will be offered a therapeutic regimen hydroxychloroquine (200 mg tablets) 800 mg on day 1, and 400 mg on days 2–7 VS Active Comparator: No Intervention- SARS-CoV-2 surveillance Isolation of patient and contact tracing as per national guidelines. |
Phase 3 | Randomized; Open Label | 2300 (≥18) | Study 1 – Clinical and virological outcome in exposed contacts [ Time Frame: Up to 14 days after start of treatment ] Study 1 – Transmission of SARS-CoV-2 in exposed contacts [ Time Frame: Up to 14 days after start of treatment ] Study 2 – Virological outcome in index cases [ Time Frame: Up to 7 days after start of treatment ] Study 2 – Clinical outcome in index cases [ Time Frame: Up to 28 days after start of treatment ] |
|
| NCT04331795 | Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis (COVIDOSE) | Experimental: Group A: Tocilizumab (beginning dose 200 mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 h. VS Experimental: Group B: Low-dose tocilizumab (beginning dose 80 mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 h. |
Phase 2 | Non-Randomized; Open Label | 32(≥18) | Clinical response [ Time Frame: Assessed for the 24 h period after tocilizumab administration ] Biochemical response [ Time Frame: Assessed every 24 h during patient's hospitalization, up to 4 weeks after tocilizumab administration ] |
|
| NCT04473170 | Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19 (SENTAD-COVID) | Experimental: Group A Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry. VS Active Comparator: Group B COVID-19 Standard care. |
Phase 1/2 | Randomized; Open Label | 146(≥18) | Adverse reactions incidence. [ Time Frame: Day 0–28 ] Rate of mortality within 28-days. [ Time Frame: Day 0–28 ] Time to clinical improvement on a seven-category ordinal scale. [ Time Frame: Day 0–28 ] |
|
| NCT04349241 | Efficacy and Safety of Favipiravir in Management of COVID-19 (FAV-001) | Experimental: Favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10 VS Active Comparator: Standard of care therapy Oseltamivir 75 mg 12 hourly for 5–10 days and Hydroxychloroquine 400 mg 12 hourly day −1 followed by 200 mg 12 hourly daily on day-2 to day-5–10. |
Phase 3 | Randomized; Open Label | 100 (18 to 80 y/o) | Viral clearance [ Time Frame: 14 days ] Clinical improvement [ Time Frame: 14 days ] |
|
| NCT04475120 | Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients | Experimental: Group 1a (COVID-19 mild to moderate patients) received liposomal lactoferrin in 200 mg cps (equal to 100 mg of lactoferrin), 10 capsules per day for patients weighing less than or equal to 70 kg divided into 5 capsules in the morning and 5 capsules in the evening for 30 days for a total of 1 g of lactoferrin / day; patients with body weight over 70 kg, 15 capsules per day divided into 3 administrations / day for 30 days for a total of 1.5 g of lactoferrin per day; intra-nasal spray: 2 sprays per nostril 3 times a day, inhaling deeply during administration. Group 2a (COVID-19 asymptomatic patients) received liposomal lactoferrin in 200 mg tablets (equal to 100 mg of lactoferrin), 5 capsules per day, 3 of which in the morning and 2 in the evening for 30 days (total dosage 500 mg of apo-lactoferrin per day); intra-nasal spray: 2 sprays per nostril 3 times a day, inhaling deeply during administration. Before administration, it was recommended to carefully clean the nasal cavity. VS No Intervention: Group 1b 15 mild-to-moderate symptomatic patients in hospitalization regimen were enrolled in the control group 1b to be paired by age group and gender to the aforementioned experimental group (1a) Group 2b 15 asymptomatic patients were enrolled as a control group (group 2b) to be paired by age group and gender to the aforementioned experimental group (2a) |
Phase 2/3 | Randomized; Open Label | 60(≥20) | Rate of viral clearance Time to viral clearance [ Time Frame: 30 days ] time to naso-oro-pharingeal swab negativization | |
| NCT04345276 | Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection | Experimental: Danoprevir + Ritonavir groupDanoprevir 100 mg, one tablet each time, twice per day, up to 10 days. Ritonavir 100 mg, one tablet each time, twice per day, up to 10 days. | Phase 4 | Single Group Assignment;Open Label | 10 (18 to 75 y/o) | Rate of composite adverse outcomes [ Time Frame: Within 10 days after administration ] Defined as SPO2 ≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300 mmHg or a respiratory rate ≥ 30 breaths per min without supplemental oxygen min without supplemental oxygen |
|
| NCT04346446 | Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients | Experimental: Convalescent Plasma + Supportive Care Convalescent plasma from recovered COVID-19 patients will be transfused to severely sick COVID-19 infected patients VS Active Comparator: Random Donor Plasma + Supportive Care |
Phase 2 | Randomized; Open Label | 29(≥18) | Proportion of patients remaining free of mechanical ventilation in both groups [ Time Frame: Day 7 ] | |
| NCT04343092 | Efficacy of Ivermectin as Add on Therapy in COVID19 Patients | Experimental: Ivermectin (IVM) 12 mg /weekly + Hydroxychloroquin (HCQ) 400 mg/daily + Azithromycin (AZT) 500 mg daily VS No Intervention: Hydroxychloroquine 400 mg/daily + azithromycin 500 mg daily |
Phase 1 | Randomized; Double blind | 100(≥18) | Number of cured patients [ Time Frame: 4 weeks ] | |
| NCT04475588 | Efficacy and Safety of Itolizumab in COVID-19 Complications | Experimental: Best supportive care with Itolizumab Start at 1.6 mg/kg dose IV infusion, if well tolerated and improvement in patient observed, investigator has the discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen. VS Active Comparator: Best supportive care |
Phase 2 | Randomized; Open Label | 30(18 to 99 y/o) | One-month mortality rate between the two arms [ Time Frame: One-month ] | |
| NCT04376814 | Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19 | Experimental: Test Group In this group, Patients will be given a stat dose of 1600 mg Favipiravir tablets for the first time, and for next time they will be given 600 mg of favipiravir tablets three times per day for 7 days, plus 200 mg of Hydroxychloroquine two times per day will be given to patients for 7 days. VS Active Comparator: Control Group In this group, Patients will be given a stat dose of 400 mg Hydroxychloroquine tablets plus 200/50 mg of Lopinavir/Ritonavirtwo times per day for seven days. |
Not Applicable | Non-Randomized; Open Label | 40 (16 to 100y/o) | Mortality [ Time Frame: Up to 28 days ] long of hospitalization [ Time Frame: Up to 28 days ] Laboratory Treatment Response (Blood cell count) [ Time Frame: Up to 28 days ] Laboratory Treatment Response (CRP) [ Time Frame: Up to 28 days ] Dyspnea [ Time Frame: Up to 28 days ] Oxygen saturation without supplemental oxygen. [ Time Frame: Up to 28 days ] Oxygen therapy [ Time Frame: Up to 28 days ] |
|
| NCT04407208 | Convalescent Plasma Therapy in Patients With COVID-19 | Experimental: Convalescent plasma recipient Recipients receive 3 times of each 100 ml convalescent plasma on day 0, 3, and 6 |
Phase 1 | Single Group Assignment;Open Label | 10(≥18) | Plaque reduction neutralization test (PNRT) [ Time Frame: day 7 after first transfusion ] D-dimer [ Time Frame: day 1, 4, 7, 14 after first transfusion ] C-Reactive Protein (CRP) [ Time Frame: day 1, 4, 7, 14 after first transfusion ] International Normalized Ratio (INR) [ Time Frame: day 1, 4, 7, 14 after first transfusion ] Oxygenation Index [ Time Frame: day 1, 4, 7, 14 after first transfusion ] Chest X-ray [ Time Frame: day 1, 4, 7, 28 after first transfusion ] |
|
| NCT04342650 | Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II) | Active Comparator: Intervention CQ 450 mg twice daily (3 tablets of 150 mg, every 12 h) on day 1, followed by CQ 450 mg once daily (3 tablets of 150 mg) from D2 to D5. Oral administration. VS Placebo Comparator: Placebo |
Phase 2 | Randomized; Quadruple blind | 152(≥18) | Proportion of patients with onset of severe acute respiratory syndrome (SARS) [ Time Frame: 7 days after randomization ] | |
| NCT04441424 | Convalescent Plasma Therapy on Critically-ill Novel Coronavirus (COVID-19) Patients | Experimental: Convalescent plasma group 400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1–2 h to the recipients by blood donation set. VS Control group The control group of COVID-19 patients were given Hydroxychloroquine 400 mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days. |
Not Applicable | Randomized; Open Label | 49(≥18) | Death versus survival of treated patients [ Time Frame: Up to 8 weeks ] | |
| NCT04321278 | Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II) | Experimental: Hydroxychloroquine + azithromycin Hydroxychloroquine [400 mg 2×/day, 12/12 h] + azithromycin [500 mg 1×/day] VS Active Comparator: Hydroxychloroquine Hydroxychloroquine [400 mg 2×/day, 12/12 h] |
Phase 3 | Randomized; Open Label | 440(≥18) | Evaluation of the clinical status [ Time Frame: 15 days after randomization ] | |
| NCT04323527 | Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2 (CloroCOVID19) | Active Comparator: Low Dose Chloroquine Diphosphate (5 days) Low dose chloroquine group consists of 450 mg bid (3 tablets of 150 mg + 1 placebo tablet, every 12 h) on D1, 3 × 150 mg tablets + 1 placebo followed by 4 placebo tablets 12 h later from D2 to D5, and 4 placebo tablets every 12 h, D6-D10. Oral administration or via nasogastric tube in case of orotracheal intubation. VS Active Comparator: High Dose Chloroquine Diphosphate (10 days) consists of 600 mg bid (4 tablets of 150 mg, every 12 h) for 10 days. Oral administration or via nasogastric tube in case of orotracheal intubation. |
Phase 2 | Randomized; Quadruple blind |
278(≥18) | Mortality rate reduction of 50% by day 28 [ Time Frame: 28 days after randomization ] | |
| NCT04442958 | Effectiveness of Convalescent Immune Plasma Therapy | Experimental: Convalescent Plasma Therapy Group One dose of 200 ml of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment. VS No Intervention: Non-Plasma Therapy Group Standart critical care treatment group |
Not Applicable | Randomized; Double blind | 60(18 to 90 y/o) | Plasma ferritin level [ Time Frame: 7. day ] Lymphocyte count [ Time Frame: 7. day ] D-Dimer level [ Time Frame: 7. day ] C-Reactive protein level [ Time Frame: 7. day ] Plasma procalcitonin level [ Time Frame: 7. day ] Plasma fibrinogen level [ Time Frame: 7. day ] |
|
| NCT04308668 | Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) | Experimental: Hydroxychloroquine 200 mg tablet; 800 mg orally once, followed in 6 to 8 h by 600 mg, then 600 mg once a day for 4 consecutive days VS Placebo Comparator: Placebo |
Phase 3 | Randomized; Quadruple blind | 1309(≥18) | Incidence of COVID19 Disease among those who are asymptomatic at baseline [ Time Frame: 14 days ] Overall change in disease severity over 14 days among those who are symptomatic at baseline [ Time Frame: 14 days ] |
|
| NCT04444986 | Bioequivalence Study of Favir 200 mg Film Tablet Kocak Under Fasting Conditions | Experimental: Participants first received Favicovir 200 mg FT in a fasting state. After a washout period of 48 h, they then received Avigan FT200 mg in a fasting state. VS Experimental: Participants first received Avigan 200 mg FT in a fasting state. After a washout period of 48 h, they then received Favicovir FT200 mg in a fasting state. |
Phase 1 | Randomized; Open Label | 30(18 to 40 y/o) | AUC0-tlast of favipiravir [ Time Frame: 0 to 24 h post-dose ] Cmax of favipiravir [ Time Frame: 0 to 24 h post-dose ] |
This table looks at the interventional trials that have been completed and listed on ClinicalTrials.gov.