Covid19 Clinical Trial - A Randomized Controlled Clinical Trial:

Status Terminated

Clinical Trial Summary

This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.

Clinical Trial Description

The overall objective is to evaluate the clinical efficacy and safety of hydroxychloroquine (HCQ) relative to standard of care among 350 hospitalized adult patients who have COVID-19. Primary Aim i. Clinical status (on a 7-point ordinal scale) at day 15 Clinical Status 7-point ordinal scale: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death After enrollment and randomization there will be baseline and then daily assessments of clinical status and test results and procedures during hospitalization. Course of HCQ treatment is 5 days. Participants are followed daily during hospitalization. All procedures, evaluations and treatment, including the hydroxychloroquine laboratory tests, and radiology tests are part of the usual clinical care for COVID-19 patients. This study will only collect the information obtained as part of hospital standard of care. If the information is not available, it will not be obtained by any other mechanism. After discharge there is a follow up telephone call at day 15 and day 28. Follow-up assessment includes any clinical events, adverse events, and clinic or emergency visits or hospitalizations. Participants in the HCQ arm have safety labs: CBC and Comprehensive Metabolic profile scheduled on day 7 and 14. ;

Study Design

Related Conditions & MeSH terms

COVID-19

Clinical Trial Details

NCT number	NCT04345692
Study type	Interventional
Source	Queen's Medical Centre
Contact
Status	Terminated
Phase	Phase 3
Start date	March 26, 2020
Completion date	August 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Randomized Controlled Clinical Trial: Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients — OAHU-COVID19

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms