COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04375046

M.Sc.Mahmoud Elkazzaz, M.Sc.Biochemistry

mahmoudramadan2051@yahoo.com

2020-05-05

Unknown

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: laboratory diagnosis: respiratory specimen is positive for sars-cov-2 nucleic acid by rt-pcr; or, the viral gene sequencing of the respiratory specimen is highly homologous to known novel coronavirus. fever: axillary temperature >37.3℃ respiratory variables (meets one of the following criteria): respiratory rate: rr ≥25 breaths/min oxygen saturation ≤93% at rest on room air pao2/fio2 ≤300 mmhg（1 mmhg=0.133 kpa） pulmonary imaging showed that the lesions progressed more than 50% within 24-48 hours, and the patients were managed as severe hbsag negative, or hbv dna ≤10^4 copy/ml if hbsag positive; anti-hcv negative; hiv negative two weeks prior to signed informed consent form (icf) appropriate ethics approval and icf -

- age <18 years; age >80 years - pregnant or breast feeding woman or with positive pregnancy test result p/f <100 mmhg - moribund condition (death likely in days) or not expected to survive for >7 days refusal by attending md - not hemodynamically stable in the preceding 4 hours (map ≤65 mmhg, or sap <90 mmhg, dap <60 mmhg, vasoactive agents are required) - patient on invasive mechanical ventilation or ecmo - patient in other therapeutic clinical trial within 30 days before icf - receive any other ace inhibitors (acei), angiotensin-receptor blockers (arb) treatment within 7 days before icf - chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before icf - hematologic malignancy (lymphoma, leukemia, multiple myeloma) - other patient characteristics (not thought to be related to underlying covid-19) that portend a very poor prognosis (e.g, severe liver failure, and ect) - known allergy to study drug or its ingredients related to renin-angiotensin system (ras), or frequent and/or severe allergic reactions with multiple medications - other uncontrolled diseases, as judged by investigators - body weight ≥85 kg

2

Kafrelsheikh University

18

80

None

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

24

Viral load over time;Time course of body temperature (fever)

None

Phase 1

[{"arm_notes": "", "treatment_id": 1073, "treatment_name": "Recombinant bacterial ace2 receptors(rbace2)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]