COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN21085622

Mostafa Salah

mostafa.salah@tcdmena.com

2021-03-23

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Written informed consent signed and dated by the study subject or their legal representatives 2. Age =18 years old 3. Female or male patients with laboratory-confirmed symptomatic COVID-19 (SARS-CoV-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected <72 hours before randomization 4. Patients with any category of the following disease severity: 4.1. Moderate: 4.1.1. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion 4.1.2. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, saturation of oxygen (SpO2) ?90% on room air at sea level, heart rate =90 beats per minute 4.1.3. No clinical signs indicative of severe or critical illness severity 4.2. Severe (not critical): meeting the following criteria: 4.2.1 Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress 4.2.2. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate =30 per minute, heart rate =125 per minute, SpO2 =90% on room air at sea level or PaO2/FiO2 <300 4.2.3. No criteria for critical severity 5. Radiographic evidence of pulmonary infiltrate

1. Critically severe COVID-19 acute respiratory distress syndrome (ARDS) cases requiring invasive mechanical ventilation at screening 2. Patients who have a severe concomitant illness that affects survival, including uncontrolled malignant tumor, blood dyscrasia, active bleeding, or patients with shock/or multiple organ failure at screening 3. Hypersensitivity or contraindication to any of the drugs used in the study 4. Patients with liver disease or cirrhosis (Child-Pugh >9 for ravidasvir and ?12 for daclatasvir) or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) 5. Cardiac ischemia with history of recurrent angina, clinically symptomatic cardiac abnormalities, or requirement for cardiac pacemaker 6. History of any malignancy within the last 5 years 7. History of solid organ or bone marrow transplantation 8. Patients who received treatment with any other investigational drug/device or involved in another clinical trial within 6 months prior to Screening 9. People living with HIV 10. Pregnant or breastfeeding subjects 11. Patients unable to comply with the procedures described in the protocol 12. Mentally or neurologically disabled patients not able to consent to their participation in the study

3

European Egyptian Pharmaceutical Industries (EEPI)

18

100

Egypt

Moderate disease at enrollment

3: Moderate disease at enrollment

120

Measured using case report forms unless otherwise indicated 1. Sum of the counted symptoms (fever; headache; generalized aches (myalgia/arthralgia); respiratory distress combined with no evidence of deterioration (ICU admission and mechanical ventilation) at days3; 7 and 10 2. Mean Oxygen saturation from day 1 to day 10 (based on daily recording as per CRF)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1712, "treatment_name": "Ravidasvir+sofosbuvir", "treatment_type": "Antivirals", "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"}]