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Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia

NCT04703608 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2021-06-04

No results posted yet for this study

Summary

The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.

Conditions

Interventions

DRUG

Ivermectin

Ivermectin 0.3-0.4mg/Kg daily for 3 days.

DRUG

ASP

Aspirin 150mg daily for 28 days or until hospital discharge (whichever is sooner)

DRUG

Placebo

Non-identical placebo

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Effua Usuf, MBChB, PhD · Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine

  • Behzad Nadjm, MBChB, FRCP · Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine

  • Anna Roca, PhD · Medical Research Council The Gambia at London School of Hygiene & Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-22
Primary Completion
2022-03-31
Completion
2022-07-31

Countries

  • The Gambia

Study Locations

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Entities

Drugs
Diseases

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 NCT04703608 on ClinicalTrials.gov