Lactoferrin for Prevention of COVID-19 in Health Care Workers (LF-COVID)
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|ClinicalTrials.gov Identifier: NCT04526821|
Recruitment Status : Terminated (The study was interrupted due to the arrival and distribution of the vaccine to hospital workers in Peru)
First Posted : August 26, 2020
Last Update Posted : December 9, 2021
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|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2||Drug: Bovine Lactoferrin Dietary Supplement: Maltodextrin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Bovine Lactoferrin for the Prevention of COVID-19 Infection in Physicians and Nurses in Hospitals in Lima, Peru: a Double Blinded Randomized Clinical Trial (LF-COVID)|
|Actual Study Start Date :||October 17, 2020|
|Actual Primary Completion Date :||February 10, 2021|
|Actual Study Completion Date :||February 10, 2021|
Experimental: Bovine Lactoferrin
Bovine Lactoferrin plus standard measures of personal protection.
Drug: Bovine Lactoferrin
Bovine Lactoferrin 600mg daily for 12 weeks (3 chewable tablets of 100mg , twice a day), for 12 weeks plus personal portection provided from the hospital.
Other Name: Lactoferrin
Placebo Comparator: Maltodextrin
Maltodextrin plus standard measures of personal protection.
Dietary Supplement: Maltodextrin
Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.
- Number of COVID-19 infections during the 12 weeks of intervention [ Time Frame: Twelve weeks ]The primary study outcome will be defined by IgM, IgG and/or RT-PCR positivity for SARS-CoV 2.
- Severity of the COVID-19 infection [ Time Frame: Twelve weeks ]Severity of SARS-CoV-2 infection (asymptomatic, mild, moderate, severe infection), assessed by the World Health Organization definitions
- Duration of symptoms of the COVID-19 infection [ Time Frame: Twelve weeks ]Duration of symptomatic SARS-CoV-2 infection defined by the number of days with SARS-CoV-2 symptomatology.
- Frecuency of symptoms of the COVID-19 infection [ Time Frame: Twelve weeks ]Frecuency of symptoms of SARS-CoV-2 infection: fever, fatigue, nonproductive cough, anorexia, myalgias, dyspnea, productive cough, taste and smell disorders, headache, rhinorrhea, nausea, diarrhea, and abdominal pain
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 59 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526821
|Hospital Nacional Arzobispo Loayza|
|Lima, Lim, Peru, 15082|
|Hospital Cayetano Heredia|
|Lima, Peru, 15102|
|Principal Investigator:||Theresa J Ochoa, MD, PhD||Universidad Peruana Cayetano Heredia|
|Responsible Party:||Universidad Peruana Cayetano Heredia|
|Other Study ID Numbers:||
|First Posted:||August 26, 2020 Key Record Dates|
|Last Update Posted:||December 9, 2021|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data collected during the trial, after deidentification, will be shared with researchers who provide a methodological sound study protocol previously approved by an independent ethics committee.|
Statistical Analysis Plan (SAP)
|Time Frame:||Immediately following publication of the study,|
|Access Criteria:||Contact the study PI ( Theresa.email@example.com)|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Health Care Workers