Hydroxychloroquine, Azithromycin in the Treatment of Covid-19

NCT04405921 | Unknown Phase 3 DMC

• 1 other identifier: PACTT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficay and tolerance of 5-days course of hydroxychloroquine or hydroxychloroquine and azithromycin of patients with COVID-19 infection. The investigators will undertake a randomized, double-blind, controlled Trial in the region of Sousse Tunisia

Conditions

SARS-CoV-2 Pneumonia; COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical recovery at day-14, from the start of treatment.

  Clinical recovery is defined as a complete resolution clinical signs appeared during the medical history and related to COVID-19.

  14 days

Secondary Outcomes (1)

• Viral Clearance via RT-PCR at day 5- 7-10 and day 14

  5- 7-10 and day 14

Study Arms (2)

Hydroxychloroquine associated to azithromycin

EXPERIMENTAL

Hydroxychloroquine: 200 mg twice a day orally or via gastric tube (total 400 mg/day) for 5 days. Azithromycin: 500 mg at day 1 then 250 mg/day for 4 days. with standard of care in association to treatments.

Drug: Hydroxychloroquine 200 Mg Oral Tablet; Drug: Azithromycin 250 MG

Hydroxychloroquine with placebo

ACTIVE COMPARATOR

Hydroxychloroquine: 200 mg twice a day orally or via gastric tube (total 400 mg/day) for 5 days. with standard of care in association to treatments.

Drug: Hydroxychloroquine 200 Mg Oral Tablet

Interventions

Hydroxychloroquine 200 Mg Oral Tablet DRUG

orally or via gastric tube

Also known as: Plaquenil

Hydroxychloroquine associated to azithromycin; Hydroxychloroquine with placebo

Azithromycin 250 MG DRUG

orally or via gastric tube

Also known as: Azro 250

Hydroxychloroquine associated to azithromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PositiveSARS-COV-2 RT-PCR in hospitalized patients in University Hospital Farhat Hached in Sousse Tunisia.
• Had either not received hydroxychloroquine before or had received hydroxychloroquine for at least 1 day and could tolerate a dose of 200 mg of hydroxychloroquine/day.

You may not qualify if:

• Unableto take oral medication, pregnancy or breast feeding, immune-compromised patients,
• Contraindicationto the studied medications

Sponsors & Collaborators

• Centre Hôpital Universitaire Farhat Hached: lead

Study Sites (1)

University Hospital Farhat Hached

Sousse, 4000, Tunisia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Amel Letaief, Professor

CONTACT

21673102501; ameletaief@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of infectious diseases

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 28, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)