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Treatment for COVID-19 in High-Risk Adult Outpatients

NCT04354428 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2022-08-08

Study results available
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Summary

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

Conditions

Interventions

DRUG

Ascorbic Acid

Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy

DRUG

Hydroxychloroquine Sulfate

Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy

DRUG

Azithromycin

Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy

DRUG

Folic Acid

Eligible participants in a household will receive folic acid and an additional intervention drug

DRUG

Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]

Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy

Sponsors & Collaborators

Principal Investigators

  • Christine Johnston, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2020-11-03
Completion
2020-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04354428 on ClinicalTrials.gov