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

NCT04287686 | Withdrawn DMC

• 1 other identifier: GIRH-APN01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

SARS-CoV-2; Renin-angiotensin-system (RAS)

Outcome Measures

Primary Outcomes (2)

• Time course of body temperature (fever)

  Compare the time course of body temperature (fever) between two groups over time.

  14 days

• Viral load over time

  Compare viral load between two groups over time.

  14 days

Secondary Outcomes (25)

• P/F ratio over time

  14 days

• Sequential organ failure assessment score(SOFA score) over time

  14 days

• Pulmonary Severity Index (PSI)

  14 days

• Image examination of chest over time

  14 days

• Proportion of subjects who progressed to critical illness or death

  14 days

Study Arms (2)

rhACE2 group

EXPERIMENTAL

0.4 mg/kg IV BID for 7 days (unblinded) + standard of care

Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)

Control group

NO INTERVENTION

Standard of care; no placebo

Interventions

Recombinant human angiotensin-converting enzyme 2 (rhACE2) DRUG

In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days.

rhACE2 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

GCP Office of The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• Zhang X, Li S, Niu S. ACE2 and COVID-19 and the resulting ARDS. Postgrad Med J. 2020 Jul;96(1137):403-407. doi: 10.1136/postgradmedj-2020-137935. Epub 2020 Jun 10.

  PMID: 32522846 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

alunacedase alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yimin Li, PhD, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Physician

Model Details: 2-arm pilot study

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: February 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)