Trials / Withdrawn
WithdrawnNCT04287686
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
A Randomized, Open Label, Controlled Clinical Study to Evaluate the Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) in Adult Patients With COVID-19
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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 to produce statistically significant results in the major endpoints. The investigators will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted. Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug. It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group. Experimental group: 0.4 mg/kg rhACE2 IV BID and standard of care Control group: standard of care Intervention duration: up to 7 days of therapy No planned interim analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant human angiotensin-converting enzyme 2 (rhACE2) | In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days. |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2020-02-27
- Last updated
- 2020-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04287686. Inclusion in this directory is not an endorsement.