Phase 2 Completed N=47 Randomized Triple-blind Treatment

Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 Patients

SARS-CoV-2 infection

Source: ClinicalTrials.gov NCT04497389 ↗

Enrolled (actual)

Serious AEs

14.9%

Results posted

Dec 2023

Primary outcomePrimary: C-reactive Protein — -3.6; -5.5 mg/dL

Summary

The purpose of this study is to explore the effectiveness of processed human amniotic fluid as a treatment for COVID-19.

Outcome Measures

Outcome	Result	p-value
PRIMARY C-reactive Protein	-3.6; -5.5	—

Eligibility Criteria

Inclusion criteria

Age >18
SARS CoV-2 laboratory positive test, obtained within 14 days of enrollment
Hospitalized
COVID-19 symptomatic (cough, fevers, shortness of breath, and/or sputum production)
Has a room air pulse oximetry of ≤94% and requires supplemental oxygen therapy
Patients of childbearing potential who agree to use acceptable methods of contraception for 90 days after last administration of study investigational product (IP)
Patients who are receiving standard of care therapies for COVID-19 that are not FDA approved are eligible for this study
Subjects must be able to consent to the study (i.e., Glasgow Coma Scale score of ≥14)
Patients are required to have controlled blood pressure of 12 liters per minute via non-rebreather (NRB) or >80% oxygen via high flow nasal cannula
Patients who, in the opinion of the PI, have impending respiratory failure, defined as requiring rapidly escalating oxygen supplementation
Patients with a hemoglobin 3x normal
Patients with untreated HIV infection
Patients diagnosed with end-stage organ disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04497389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.