Lactoferrin for Prevention of COVID-19 in Health Care Workers

• Status: Terminated
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: All

Summary

Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection. Participants will be randomized to receive daily bovine lactoferrin plus standard measures during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target enrollment is 336 participants. Each study participant will be monitored twice a week for symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Peruana Cayetano Heredia
• Collaborator: Hospital Nacional Arzobispo Loayza
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• Man or woman over 18 and under 60 years old

• Physicians or nurses or nurse assitant who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru.

• Healthy participants, without COVID-19 suggestive symptoms

• Participant who wants to participate and signs the informed consent.

Exclusion Criteria:

• Participant who had a previous diagnosis of COVID-19.

• Participant positive in the initial screening for IgM or IgG or a positive RT-PCR for SARS-CoV-2.

• Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological disease.

• Pregnant woman.

• Participant that are part of another clinical trial or are taking any supplement or preventive treatment for COVID-19.

• Participant with known allergy to cow's milk protein.