COVID-19 Clinical Trial
— PACTTOfficial title:
Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 Pneumonia: A Randomized,Open-label,Controlled Clinical Trial
NCT number | NCT04405921 |
Other study ID # | PACTT |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | March 2021 |
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
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | March 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | University Hospital Farhat Hached | Sousse |
Lead Sponsor | Collaborator |
---|---|
Centre Hôpital Universitaire Farhat Hached |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Viral Clearance via RT-PCR at day 5- 7-10 and day 14 | RT-PCR will be realized in same laboratory | 5- 7-10 and day 14 |
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