A Phase 3 interventional study of HCQ and Azithromycin in COVID 19 and Patients Hospitalized, sponsored by Abderrahmane Mami Hospital. Withdrawn at 1 site in Tunisia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by Abderrahmane Mami Hospital · Phase 3, Interventional, and Treatment
Evaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
Arm 1:
Arm 2:
Arm 3:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →Abderrahmane Mami Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Confirmed patient COVID19 positive with clinical signs of acute lower respiratory infection with signs of pneumonia or bronchitis: fever and / or cough and / or difficulty breathing in the absence of acute respiratory failure (PaO2> 60 mmHg) with Plus or less :
Nausea and vomiting
Exclusion Criteria:
* Hydroxychloroquine (HCQ): 600 mg on the 1st day as a starting dose then 200 mg \* 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Usual standard treatment
Drug: HCQ · Drug: Azithromycin
* HCQ: 600 mg on the 1st day as a starting dose then 200 mg \* 2 / D for 9 days * Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Zinc: 220 mg per day for 10 days * Usual standard treatment
Drug: HCQ · Drug: Azithromycin · Dietary Supplement: Zinc
* Azithromycin: 500 mg (1st day) then 250 mg / D for 4 days * Doxycycline: 200 mg per day for 10 days. * Usual standard treatment
Drug: Azithromycin · Drug: Doxycycline
600 mg on the 1st day as a starting dose then 200 mg \* 2 /D for 9 days
500 mg (1st day) then 250 mg / D for 4 days
200 mg per day for 10 days
220 mg per day for 10 days
Evaluate the rate of patients cured at the end of the study.
The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
Time frame: 2 months
Evaluate the rate of patients are pauci-symptomatic at the end of the study.
A patient will be defined as pauci-symptomatic if presence: * Light dry cough * Discomfort, * More or less : * Headache, * Muscle pain
Time frame: 2 months
Evaluate the rate of patients with worsening clinical signs
Patients require transfer to intensive care with the appearance of: * Acute respiratory failure: PaO2 \<60 mmHg in AA gold * Signs of circulatory insufficiency: mottling, tachycardia, systolic BP ≤90mmHg or having dropped by 40 mmHg compared to base BP or * Confusion or alteration of the state of consciousness
Time frame: 2 months
Plan to share: No
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Abderrahmane Mami Hospital