Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19

• Status: Withdrawn
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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 rhACE2 or control patients, to help determine whether a subsequent Phase 2B trial is warranted.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Criteria

Inclusion Criteria:

1. 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.

2. Fever:

Axillary temperature >37.3℃

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

4. 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)

5. Appropriate ethics approval and

6. ICF

Exclusion Criteria:

• 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