Lactoferrin for Prevention of COVID-19 in Health Care Workers (LF-COVID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04526821|
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2||Dietary Supplement: Bovine Lactoferrin Dietary Supplement: Maltodextrin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||336 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)|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Bovine Lactoferrin
Bovine Lactoferrin plus standard measures of personal protection.
Dietary Supplement: 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
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
|Contact: Theresa J Ochoa, MD, PhD||+51996505308||Theresa.J.Ochoa@uth.tmc.edu|
|Hospital Nacional Arzobispo Loayza|
|Lima, Lim, Peru, 15082|
|Contact: Eddie Angles, MD +51996470205 firstname.lastname@example.org|
|Contact: Meylin Aphang, MD, Msc +51965055488 email@example.com|
|Principal Investigator: Eddie Angles, MD|
|Sub-Investigator: Meylin Aphang, MD, Msc|
|Sub-Investigator: Jorge Florez, MD|
|Hospital Cayetano Heredia|
|Lima, Peru, 15102|
|Contact: Carlos Medina, MD +51994311626 firstname.lastname@example.org|
|Contact: Fernando Mejia, MD, Msc +51999862832 email@example.com|
|Principal Investigator: Carlos Medina, MD|
|Sub-Investigator: Fernando Mejia, MD, Msc|
|Principal Investigator:||Theresa J Ochoa, MD, PhD||Universidad Peruana Cayetano Heredia|