Publication Elgazzar A, Research Square , 2020 (preprint)
Funding: No specific funding (No funding/support )
Conflict of interest: No
Blinding: double blinding
Multicenter / Egypt |
Follow-up duration (days): 25
- 18 years up to 80 years old;
- Not participating in other clinical trials within 30 days from administration of the study drugs;
- Patients diagnosed with COVID-19 infection with at least one positive rt-PCR result from nasopharyngeal/oropharyngeal swab;
- Severe COVID-19 confirmed cases, fulfilling any of the following criteria:
a. Respiratory rate more than 30/min.,
b. Blood oxygen saturation of less than 93%,
c. PaO2/FiO2 ratio of less than 200,
d. Lung infiltrates >50% of the lung fields or rapid progression within 24-48 hours,
e. Patients need respiratory support e.g. high flow oxygen noninvasive or invasive mechanical
|Exclusion criteria||- Pregnancy;
- Critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; Presence of shock; other organ failure that requires monitoring and treatment in the ICU;
- Mild or moderate COVID-19 confirmed cases;
Mild symptoms such as anosmia, loss of taste, fever or respiratory tract symptoms, gastrointestinal symptoms, etc.; free chest imaging;
Moderate Cases: Patients have symptoms such as fever, respiratory tract symptoms, gastrointestinal symptoms, etc. and pneumonia manifestations can be seen in chest imaging;
- Hydroxychloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
0.4 mg/kg body weight orally, maximum 4 tablets (6 mg/tablet) once daily dose for 4 days
Hydroxychloroquine ( / )
200 participants (n1=100 / n2= 100)
|Characteristics of participants|
Mean age : 58.9
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=*
|In the register|
1. Number of participants with improvement of clinical condition (symptoms and signs) [Time Frame: 3 months]
improvement of dyspnea using mMRC scale, disappearance of fever using thermometer, Fatigue using Fatigue Assessment Scale (FAS), and improvement of Oxygen saturation using pulse oximeter.
2. Reduction of recovery time, hospital stay days and mortality rate [Time Frame: 3 months]
recording days of clinical improvement (recovery time), hospital stay days and mortality rate.
|In the report|
Clinical, laboratory investigations improvement and/or 2 consecutive negative PCR tests taken at least 48 hours apart.
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
The treatment groups in this report were extracted as 2 RCTs based on baseline severity: mild/moderate and severe COVID-19. In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The trial was registered after the study was completed. A participant flow diagram was not presented. Mortality was one of the primary outcomes in the retrospective registry but was not a primary outcome in the report. The method of analysis was not reported. There were no other substantive differences between the registry and pre-print in study population, procedures, or interventions. Overall the study was not clearly reported.
On April 07th,2021, we received additional information from authors on this study. This study was updated with data from contact with authors on April 12th, 2021.