CovidResearchTrials by Shray Alag


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Hydroxychloroquine and AzithromycinWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug212 Artemesia annua Wiki 0.71
drug385 Blood samples collection Wiki 0.71
drug261 Azinc Wiki 0.71
drug2187 Saliva collection Wiki 0.32
drug512 Camostat Mesilate Wiki 0.32
drug1270 Ivermectin Wiki 0.17

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.14
D012127 Respiratory Distress Syndrome, Newborn NIH 0.14
D012128 Respiratory Distress Syndrome, Adult NIH 0.12
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID

Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients. It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.

NCT04371406 Covid-19 Drug: Hydroxychloroquine and Azithromycin Dietary Supplement: Azinc

Primary Outcomes

Description: Unfavorable outcome defined by the onset of at least one of the following between randomization and day 14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air

Measure: Rate of patients with occurrence of an unfavorable outcome between randomization and day 14

Time: between randomization and day14

Description: Ancillary virological study : evolution of viral load between day 0 and day 14, measured by the threshold cycle,Ct, with PCR on naso-pharyngeal swab

Measure: Primary outcome of ancillary virological study : evolution of viral load between day 0 and day 14

Time: between day 0 and day 14

Secondary Outcomes

Measure: The all-cause mortality rate at day 14

Time: day 14

Measure: The all-cause mortality rate at day 28

Time: day 28

Description: Unfavorable outcome defined by the onset of at least one of the following between randomization and day 28: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air

Measure: Rate of patients with occurrence of an unfavorable outcome between randomization and day 28

Time: between randomization and day 28

Measure: The rate of use of mechanical ventilation at day 14

Time: day 14

Measure: The rate of use of mechanical ventilation at day 28

Time: day 28

Measure: The Intensive Care Unit admission rate at day 14

Time: day 14

Measure: The Intensive Care Unit admission rate at day 28

Time: day 28

Measure: Number of days of hospitalization for any cause between day 0 and day 14

Time: between randomization and day 14

Measure: Number of days of hospitalization for any cause between day 0 and day 28

Time: between randomization and day 28

Description: Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours

Measure: The time to resolution of all COVID symptoms at day 14

Time: day 14

Description: Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours

Measure: The time to resolution of all COVID symptoms atday 28

Time: day 28

Measure: The rate of use of oxygen therapy at day 14

Time: between randomization and day 14

Measure: The rate of use of oxygen therapy at day 28

Time: between randomization and day 28

Measure: The rate of use of secondary antibiotic therapy (after day 2) at day 14

Time: between randomization and day 14

Measure: The rate of use of secondary antibiotic therapy (after day 2) at day 28

Time: between randomization and day 28

Description: Clinical status on a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Clinical status at day 14

Time: day 14

Description: Clinical status on a 7-point ordinal scale : Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.

Measure: Clinical status at day 28

Time: day 28

Measure: number of serious adverse events at day 14

Time: day 14

Measure: number serious adverse events at day 28

Time: day 28

Measure: number of adverse events at day 14

Time: day 14

Measure: number of adverse events at day 28

Time: day 28

Measure: The rate of patients with treatment withdrawal

Time: day 14

Description: Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 8

Measure: Ancillary virological study : rate of patients with negative viral load at day 8

Time: day 8

Description: Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 14

Measure: Ancillary virological study : rate of patients with negative viral load at day 14

Time: day 14

2 Randomized, Multi-arm Phase II Trial of Novel Agents for Treatment of High-risk COVID-19 Positive Patients

This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.

NCT04374019 COVID Sars-CoV2 Drug: Hydroxychloroquine and Azithromycin Drug: Ivermectin Drug: Camostat Mesilate Dietary Supplement: Artemesia annua

Primary Outcomes

Description: Proportion of patients experiencing clinical deterioration. Clinical deterioration is defined as a less than a 2-point change from the initial COVID 7-Point Ordinal Outcomes Scale within 14 days from the study start. This scale ranges from 1-7. Lower scores indicate worse outcomes (death); higher scores indicate fewer symptoms and better outcomes.

Measure: Clinical Deterioration

Time: 14 days

Secondary Outcomes

Description: The change in (clearance of) viral RNA will be measured by PCR testing at days 1, 14, 28, and 40 days.

Measure: Change in Viral Load

Time: 40 days

Description: Percentage of patients that experience severe respiratory or other organ failure.

Measure: Rate of Organ Failure

Time: 28 days

Description: Percentage of patients requiring ICU admission or ventilation.

Measure: Progression to ICU Care or Ventilation

Time: 28 days

Description: Clinical status will be assessed using the COVID 7-Point Ordinal Outcomes Scale. This scale ranges from 1-7. Lower scores indicate worse outcomes; higher scores indicate fewer symptoms and better outcomes.

Measure: Change in Clinical Status

Time: 14 days

Description: Percentage of patients who have died by day 14.

Measure: Mortality

Time: 14 days

Description: Percentage of patients experiencing severe adverse events, defined as grade 3 non-hematologic or greater by DMID Toxicity Scale for Determining Severity of Adverse Events.

Measure: Rate of severe adverse events

Time: 14 days

Description: Number of days patients do not require oxygen supplementation.

Measure: Oxygen-free days

Time: 28 days

Description: Number of days patients do not require mechanical ventilation.

Measure: Ventilator-free days

Time: 28 days

Description: Number of days patients do not require vasopressor treatment.

Measure: Vasopressor-free days

Time: 28 days

Description: Number of days patients do not require ICU services.

Measure: ICU-free days

Time: 28 days

Description: Number of days patients do not require hospitalization.

Measure: Hospital-free days

Time: 28 days

Description: Proportion of patients meeting Hy's law criteria.

Measure: Patients meeting Hy's Law criteria

Time: 28 days

Description: Proportion of patients with changes in the following liver function tests: Any ALT or AST ≥ 5 x ULN; any AST or ALT ≥ 3 x ULN together with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (eosinophil percent or count above the ULN); Persistent ALT ≥ 3 x ULN for a period of more than 4 weeks

Measure: Liver Function

Time: 28 days

Description: Proportion of patients with significant changes in ECG findings, including heart rate, ECG intervals (PR, QTcB, QTcF), conduction changes, or abnormalities including severe QTc prolongation of > 500 ms.

Measure: Heart Function

Time: 28 days


No related HPO nodes (Using clinical trials)