COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12158

Amal Mohamed

amalasaic@gmail.com

2020-06-19

Recruiting

RCT

Randomized

Factorial

Blind label

single-center

Treatment

Age:18-60 years old, recently diagnosed (within 24 h) and moderate symptoms of the disease ongoing SARS-CoV-2 infection confirmed in upper or lower respiratory tract specimens with real time reverse transcriptase polymerase chain reaction (RT-PCR), willingness to participate. Pneumonia on computed tomography of the chest will not be mandatory for inclusion.

age below 18 years, severe conditions including malignancies, heart, liver, or kidney disease, poorly controlled metabolic diseases, pregnancy or lactation, severe hepatic impairment (e.g. Child Pugh grade C, alanine aminotransferase more than fivefold the upper limit), severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) , receipt of continuous renal replacement therapy, hemodialysis, peritoneal dialysis, allergy to heparin (including any history of heparin-induced thrombocytopenia), pulmonary hemorrhage in the previous 3 months, uncontrolled bleeding or a significant bleeding disorder, an intracranial hemorrhage in the past 12 months and patients with mild and severe COVID-19 will be excluded.

2

Dr Tarek Ismail

18

60

Egypt

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

The primary outcome will be the average daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2) while the patient on room air for 7 days.

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]