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Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 (PACTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405921
Recruitment Status : Unknown
Verified June 2020 by Amel Letaief, Centre Hôpital Universitaire Farhat Hached.
Recruitment status was:  Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Amel Letaief, Centre Hôpital Universitaire Farhat Hached

Study Description
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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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Pneumonia COVID-19 Drug: Hydroxychloroquine 200 Mg Oral Tablet Drug: Azithromycin 250 MG Phase 3

Detailed Description:

There is a critical need to identify effective treatments and a number of molecules have been suggested, but The investigators still do not have enough evidence about their efficacy, to treat COVID-19 pneumonia.

One of the most tested treatments was the use of Chloroquine or Hydroxychloroquine associated or not to azithromycin.

Studies have indicated that chloroquine (CQ) shows antagonism against COVID-19 in vitro. It's known to block virus infection by increasing endosomal pH required for virus/cell fusion, as well as interfering with the glycosylation of cellular receptors of SARS-CoV. It's also demonstrated that CQ functioned at both entry, and at postentry stages of the 2019-nCoV infection in Vero E6 cells. Besides its antiviral activity, CQ has an immune-modulating activity, which may synergistically enhance its antiviral effect in vivo.

However, evidence regarding its effects in patients is limited. Among patients with COVID-19, the use of Hydroxychloroquine (HCQ) could significantly shorten time to clinical recovery (TTCR) and promote the absorption of pneumonia. This result has been presented in a randomized controlled trial using two arms HCQ versus conventional treatment. The beneficial effect of HCQ has been proven among mild severity COVID-19 pneumonia but the sample size of this study was limited to 31 patients in each group.

Gautret et al also reported that HCQ treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin. A study showed that azithromycin concentration in phagocytic cells is 40× to 150× higher than plasma concentrations. However, Gautret study has many limitations including selection biases because of non-randomization, a small sample size, and dropout of six patients from the study.

In terms of treatment duration, there is no study supporting a long course treatment of 10 days versus a short course treatment of 5 days for HCQ. This treatment is known to have a large distribution volume of 73 l/kg and a plasma half life going from 22 days to 123 days. This suggests that a short course treatment of Hydroxychloroquine and/or azithromycin could be as effective as a long course treatment.

On the other hand, there are currently no effective specific antivirals or drug combinations supported by high-level evidence, and The investigators don't know if HCQ could be effective or if it's effectiveness may be improved if it's associated with Azithromycin. In fact, this association can lead to improve pneumonia but can also increase the risk of treatment side effects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 Pneumonia: A Randomized,Open-label,Controlled Clinical Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Hydroxychloroquine associated to azithromycin
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
orally or via gastric tube
Other Name: Plaquenil

Drug: Azithromycin 250 MG
orally or via gastric tube
Other Name: Azro 250
Active Comparator: Hydroxychloroquine with placebo
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
orally or via gastric tube
Other Name: Plaquenil


Outcome Measures
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Primary Outcome Measures :
  1. Clinical recovery at day-14, from the start of treatment. [ Time Frame: 14 days ]
    Clinical recovery is defined as a complete resolution clinical signs appeared during the medical history and related to COVID-19.


Secondary Outcome Measures :
  1. Viral Clearance via RT-PCR at day 5- 7-10 and day 14 [ Time Frame: 5- 7-10 and day 14 ]
    RT-PCR will be realized in same laboratory


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unableto take oral medication, pregnancy or breast feeding, immune-compromised patients,
  • Contraindicationto the studied medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405921


Contacts
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Contact: Amel Letaief, Professor 21673102501 ameletaief@gmail.com

Locations
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Tunisia
University Hospital Farhat Hached
Sousse, Tunisia, 4000
Contact: Amel Letaief, Professor         
Sponsors and Collaborators
Centre Hôpital Universitaire Farhat Hached
More Information
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Responsible Party: Amel Letaief, Professor of infectious diseases, Centre Hôpital Universitaire Farhat Hached
ClinicalTrials.gov Identifier: NCT04405921    
Other Study ID Numbers: PACTT
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents