Status:
WITHDRAWN
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
COVID-19
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is an open label, randomized, controlled, pilot clinical study in patients with COVID-19, to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhA...
Detailed Description
This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04287686
Start Date
February 1 2020
End Date
April 1 2020
Last Update
March 17 2020
Active Locations (1)
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1
GCP Office of The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120