Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+) (COVID+PA)
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ClinicalTrials.gov Identifier: NCT04351919 |
Recruitment Status :
Withdrawn
(- Interest in the use of HCQ is controversial.)
First Posted : April 17, 2020
Last Update Posted : August 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patients With COVID19 | Drug: Hydroxychloroquine Drug: Azithromycin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | open, interventional, multicentric study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of Efficacy and Safety of HCQ and Antibiotics Administrated to Patients COVID19(+), inTunisia |
Estimated Study Start Date : | May 5, 2020 |
Estimated Primary Completion Date : | July 15, 2020 |
Estimated Study Completion Date : | July 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: HCQ Arm |
Drug: Hydroxychloroquine
400mg per day during 10 days Drug: Azithromycin 500 mg per day during 5 days |
- improvment or healing of clinical signs [ Time Frame: at the end of the study treatment - 1 month after inclusion ]no respiratory infectious signs
- Evolution of clinical signs [ Time Frame: at the end of the study treatment - 1 month after inclusion ]Low respiratory signs with severity criteria

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- confirmed COVID19 (+)
- Qt<500ms
- no severity criteria
- pauci-symptomatique patients
- signed consent form
Exclusion Criteria:
- no confirmed patient COVID19
- severity criteria
- known allegies to macrolides and HCQ
- Treated with HCQ within 1 month prior to inclusion
- hepatitis insufficiency
- Renal insufficiency
- treatment no indicated with azithro and HCQ
- hypovolemia
- complete brach block
- retinopathia
- psoriasis
- pregnancy or breastfeeding

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): NCT04351919
Tunisia | |
Eshmoun Clinical Research Centre/ Hôpital Abderrahmen Mami-Ariana | |
Tunis, Tunisia |
Responsible Party: | Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital |
ClinicalTrials.gov Identifier: | NCT04351919 |
Other Study ID Numbers: |
ECC2020-04 |
First Posted: | April 17, 2020 Key Record Dates |
Last Update Posted: | August 28, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia 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 |