A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: SARS CoV-2 Infection

Treatments: Biological: Human Amniotic Fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT04319731

131618

Details and patient eligibility

About

The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥18
• 2. Hospitalized and symptomatic (cough, fevers, SOB, or sputum production)
• 3. SARS CoV-2 laboratory positive obtained within 14 days of enrollment

Exclusion criteria

• 1. None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment groups: 1. Acute care and ICU - 10mL intravenous amniotic fluid every 24 hours for 5 days (6mL)

Treatment:

Biological: Human Amniotic Fluid