Angiotensin 1-7 as a Therapy in the Treatment of COVID-19

NCT04605887 | Unknown Phase 2

• 2 other identifiers: 0328-20-RMBMOH_2020-11-02_009463
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 ,double blind, randomized study of therapy with Angiotensin 1-7 in COVID-19 patients. 120 confirmed SARS-CoV-2 infected patients who exhibit moderate- clinical symptoms including dyspnea, cough and fever, hospitalized in the KETER department in several hospitals in Israel, will be enrolled. 60 patients will receive Ang 1-7 subcutaneously 500 mcg/kg /day. 60 patients will receive placebo : NaCl 0.9% 2 ml -control arm . Treatment duration: 14 days or until clinical improvement that enables discharge from hospital. (the shortest time will be the limiting factor in treatment duration). Follow-up-30 days. 14-30 days after discharge from hospital: we will contact the patient via phone to ask questions related to any possible adverse reaction to the drug and general health.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Need for mechanical ventilation

  Patient is intubated

  Any time from randomization up to 30 days of last study treatment dose

• Death

  death certificate

  Any time from randomization up to 30 days of last study treatment dose

Study Arms (2)

treatment group

ACTIVE COMPARATOR

Ang 1-7 subcutaneously 500 mcg/kg /day

Drug: Angiotensin 1-7

control group

PLACEBO COMPARATOR

NaCl 0.9% subcutaneously 2.0 cc once a day

Drug: Angiotensin 1-7

Interventions

Angiotensin 1-7 DRUG

Ang 1-7 subcutaneously 500 mcg/kg /day

control group; treatment group

Eligibility Criteria

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

You may qualify if:

• Respiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR
• Fever: Temperature \>37.8℃
• Moderate lung disease, defined by the following respiratory variables (meets one of the following criteria): lung infiltrates (evident by chest X-ray) not attributable to other causes plus one of the following:
• Respiratory rate: RR ≥25 breaths/min
• Oxygen saturation ≤94 % at rest on room air
• HBsAg negative, HCV negative; HIV negative
• Informed consent

You may not qualify if:

• Age \<18 years
• Pregnant or breast-feeding woman or with positive pregnancy test result
• PaO2/FiO2 ≤100 mmHg / mechanical ventilation
• Severe organ failure - not expected to survive for \>7 days
• Hemodynamically unstable in the preceding 10 hours (MAP ≤65 mmHg, or SAP \<90 mmHg, DAP \<60 mmHg, vasoactive agents are required)
• Patient on ECMO
• Patient in other therapeutic clinical trial within 30 days before enrolment
• Chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before enrolment
• 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 congestive heart failure( NYHA class III or IV, EF less than 30%,) liver cirrhosis , chronic kidney disease stave IV, V(e GFR\<30 ml/min), chronic obstructive lung disease: GOLD C,D : ≥2 exacerbations or ≥1 that required hospitalization, FEV1\<50%, GOLD 3,4)
• Atopic patients suffering from allergies

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Constant Therapeutics LLC: collaborator

Study Sites (1)

Rambam Medical Center

Haifa, 3525408, Israel

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

angiotensin I (1-7)

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

Central Study Contacts

Etty Kruzel-Davila, Dr.

CONTACT

+972-53-276-6052; e_kruzel@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: October 28, 2020
• Study Start: January 18, 2021
• Primary Completion: November 1, 2023
• Study Completion: April 1, 2024
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)