CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Hydroxychloroquine and IvermectinWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug534 Hydroxychloroquine and Azithromycin Wiki 0.71
drug239 Camostat Mesilate Wiki 0.50
drug505 Hydroxychloroquine Wiki 0.11

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D012213 Rheumatic Fever NIH 1.00
D012216 Rheumatic Diseases NIH 0.71
D003095 Collagen Diseases NIH 0.71
D001327 Autoimmune Diseases NIH 0.58

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002960 Autoimmunity HPO 0.58

There is one clinical trial.

Clinical Trials

1 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. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus, through alternative mechanisms to hydroxychloroquine, 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 Drug: Hydroxychloroquine and Azithromycin Drug: Hydroxychloroquine and Ivermectin Drug: Camostat Mesilate

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)