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PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine

NCT04353037 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-10-19

Study results available
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Summary

The proposed hypothesis is that high doses of hydroxychloroquine (HCQ) for at least 2 weeks can be effective antiviral medication both as a treatment in ambulatory patients and prophylaxis/treatment in health care workers because it impairs lysosomal function and reorganizes lipid raft (cholesterol and sphingolipid rich microdomains in the plasma membrane) content in cells, which are both critical determinants of Emerging Viral Disease (EVD) infection. This hypothesis is based on a growing literature linking chloroquine to antiviral activity. It is estimated that enough information exists to launch a clinical trial of hydroxychloroquine for COVID-19.

Conditions

  • Coronavirus
  • Corona Virus Infection

Interventions

DRUG

Group 1 HCQ

Enrolled participants randomized in Group 1 receive the HCQ drug

DRUG

Group 2 Placebo

Enrolled participants randomized in Group 2 will receive a placebo drug

Sponsors & Collaborators

Principal Investigators

  • Deneen Vojta, MD · UnitedHealth Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-07
Primary Completion
2020-07-11
Completion
2020-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353037 on ClinicalTrials.gov