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NCT04421534
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Utility of Lactoferrin as an Adjunct Therapeutic Agent for COVID-19 |
Not yet recruiting |
Phase 2|Phase 3 |
Jun/01/2020 |
Nov/01/2020 |
- Alternative id - CUKA-001
- Interventions - Drug: Lactoferrin
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 150
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Time to clinical improvement|Rate of virological cure
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NCT04427865
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Utility of Lactoferrin as a Preventive Agent for Healthcare Workers Exposed to COVID-19 |
Not yet recruiting |
Phase 2|Phase 3 |
Jul/01/2020 |
Nov/01/2020 |
- Alternative id - CUKA-002
- Interventions - Drug: prophylactic lactoferrin daily
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 200
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Incidence of SARS-CoV-2|Severity of disease in confirmed infected participants
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NCT04412395
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Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease |
Not yet recruiting |
Phase 2 |
Feb/01/2022 |
Dec/30/2022 |
- Alternative id - COVID-19_LF
- Interventions - Dietary Supplement: Lactoferrin (Apolactoferrin)|Drug: Placebo of excipient(s) will be administered
- Study type - Interventional
- Study results - No Results Available
- Locations - National Research Center, Egypt (Clinical and Molecular Pharmacology), Cairo, Giza, Egypt|Clinmax CRO (Clinical Research Organization), Cairo, Egypt|Clinical Trial Unit National Research Center, Cairo, Egypt|Egyptian Military Medical Services (Hospitals), Cairo, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 516
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Survival rate.|Rate of disease remission.|The number of patients with PCR negative results.|Mean change in the disease severity (clinical assessment).|Mean change in blood pressure.|Mean change in heart beats.|Mean change in body temperature.|Mean change in body respiratory rate.|Mean change in oxygen saturation.|Mean change in the ratio in arterial oxygen partial pressure to fractional inspired oxygen (PF ratio).|Mean change in complete blood picture (CBC).|Mean change in C reactive protein (CRP).|Mean change in erythrocyte sedimentation rate (ESR).|Mean change in D-dimer.|Mean change in ferritin.|Mean change in liver Albumin.|Mean change in total and direct Bilirubin.|Mean change in prothrombin time (PT) and partial thromboplastin time (PTT ).|Mean change in aspartate aminotransferase (AST).|Mean change in Alanine Aminotransferase (ALT).|Mean change in Blood Urea Nitrogen (BUN).|Mean change in Serum Creatinine.|Mean change in Serum Creatinine clearance.|Mean change in Glomerular filtration rate (GFR ).|The mean change in serum interleukin-1 (IL-1).|The mean change in serum interleukin-6 (IL-6).|The mean change in serum interleukin-10 (IL-10).|The mean change in serum tumor necrosis factor-alpha (TNF alpha).|Mean changes in immunoglobulin G (IgG).|Mean changes in immunoglobulin M (IgM).|The mean change in PCR viral load.|Mean change in lung CT manifestation.|Nature and severity of Adverse Events.|Time for lung recovery.|The number of missed drug doses among each treatment group.
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NCT04860219
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Lactoferrin Use in (SARS-CoV-2) Management |
Recruiting |
Not Applicable |
Jul/08/2020 |
Apr/30/2021 |
- Alternative id - COVID-1937
- Interventions - Dietary Supplement: Lactoferrin
- Study type - Interventional
- Study results - No Results Available
- Locations - Faculty of Medicine -Zagazig University, Zagazig, Egypt
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 54
- Age - 20 Years and older (Adult, Older Adult)
- Outcome measures - time to be symptoms free and normal laboratory results
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NCT04475120
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Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients |
Completed |
Phase 2|Phase 3 |
Apr/15/2020 |
Jul/02/2020 |
- Alternative id - 4220
- Interventions - Drug: liposomal lactoferrin|Drug: SOC therapy
- Study type - Interventional
- Study results - No Results Available
- Locations - University of Rome Tor Vergata, Rome, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 92
- Age - 20 Years and older (Adult, Older Adult)
- Outcome measures - Rate of viral clearance Time to viral clearance|Time to clinical improvement
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NCT04621149
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An Outpatient Study Investigating Non-prescription Treatments for COVID-19 |
Recruiting |
Phase 2 |
Nov/15/2020 |
Mar/31/2021 |
- Alternative id - Profact-01
- Interventions - Other: chlorine dioxide|Dietary Supplement: zinc acetate|Drug: Famotidine|Other: placebo|Dietary Supplement: lactoferrin, green tea extract
- Study type - Interventional
- Study results - No Results Available
- Locations - AZ Good Health Center, Tempe, Arizona, United States
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 20 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Reduction in Participant Symptoms of COVID-19|Incidence of Treatment-Emergent Adverse Events|Rate of Hospitalization|Change in Oxygen Saturation|Change in Body Temperature
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NCT04847791
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Lactoferrin in Covid-19 Hospitalized Patients |
Recruiting |
Not Applicable |
Jan/14/2021 |
Dec/31/2022 |
- Alternative id - 2020/279
- Interventions - Dietary Supplement: Bovine lactoferrin|Dietary Supplement: Placebo administration
- Study type - Interventional
- Study results - No Results Available
- Locations - ASL BI Ospedale degli Infermi, Ponderano, Biella, Italy|AOU Ospedale Maggiore della Carità, Novara, Italy
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 194
- Age - 18 Years to 99 Years (Adult, Older Adult)
- Outcome measures - intensive care unit hospitalization rate|death|proportion of discharged patients|National Early Warning Score (NEWS)|daily clinical severity score|oxygen|ferritin|IL 6|D dimers|hepcidine|ventilation|adverse events|pO2/FiO2
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NCT04526821
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Lactoferrin for Prevention of COVID-19 in Health Care Workers |
Terminated |
Phase 2 |
Oct/17/2020 |
Feb/10/2021 |
- Alternative id - SIDISI 202110
- Interventions - Drug: Bovine Lactoferrin|Dietary Supplement: Maltodextrin
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Nacional Arzobispo Loayza, Lima, Lim, Peru|Hospital Cayetano Heredia, Lima, Peru
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 209
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Number of COVID-19 infections during the 12 weeks of intervention|Severity of the COVID-19 infection|Duration of symptoms of the COVID-19 infection|Frecuency of symptoms of the COVID-19 infection
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