Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 (PACTT)
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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
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV-2 Pneumonia COVID-19 | Drug: Hydroxychloroquine 200 Mg Oral Tablet Drug: Azithromycin 250 MG | Phase 3 |
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 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 |

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.
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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 |
- 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.
- 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

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

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
Contact: Amel Letaief, Professor | 21673102501 | ameletaief@gmail.com |
Tunisia | |
University Hospital Farhat Hached | |
Sousse, Tunisia, 4000 | |
Contact: Amel Letaief, Professor |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |