COVID-19 trials registries data warehouse

http://www.drks.de/DRKS00022203

Mostafa Yakoot

yakoot@yahoo.com

2020-06-15

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

(1) Subjects or their legal representatives have signed the informed consent form (ICF).(2) Subjects are aged = 18 and = 75,(3) Has laboratory-confirmed Symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected 200mmHg under oxygen inhalation.

(1) Patients with pneumonia due to other etiology.(2) Critically severe COVID19 ARDS cases Requiring invasive mechanical ventilation at screening,(3) Patients who have severe concomitant illness that affects survival or course of the disease, including uncontrolled malignant tumor, HIV, blood dyscrasia, active bleeding or patients with shock/or multiple organ failure at screening.(4) Pregnant or lactating females.(5) Hypersensitivity or contraindication to any of the experimental drugs used in the study (Prolonged QT syndrome, G6PD deficiency, psoriasis, retinal damage or others). . (6) Patients with decompensated liver cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase (ALT) and aspartate aminotransferase (AST),(7) Renal dysfunction (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2),

3

PHARCO CORPORATE

18

75

Egypt

No restriction on type of patients

0: No restriction on type of patients

90

1. Proportion of clinical recovery (composite) within 14 & 21 days (Normalization of fever (=37.2 °C oral); Respiratory rate (=24/minute on room air); Oxygen saturation (=94% on room air)); sustained for at least 24 hours (using Exact test with Boot-Strapping). 2. Time to clinical recovery (composite) [Time frame: 21 days after randomization (using Kaplan Meier curve and Cox-regression). 3. Time to viral negativity assessed twice 48 hours apart (log10 viral load assessed by reverse transcription-PCR) during hospital stay (Kaplan Meier curve and Cox-regression).4. Mean change in Clinical status using 8 point ordinal scale [Day 3 through Day 14; 21 (using Repeated measure Factorial ANOVA test]: 1) Death; 2) Hospitalized; on invasive ventilation or ECMO; 3) Hospitalized; on NIV or HFO2; 4) Hospitalized with oxygen supplement; 5) Hospitalized; not requiring oxygen but need medical care; 6) Hospitalized; not requiring supplemental oxygen or ongoing medical care; 7) Not hospitalized; limitation on activities and/or requiring home oxygen; 8) Not hospitalized with normal activity.

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1478, "treatment_name": "Daclatasvir+sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]