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Effect of hyperimmune bovine milk & colostrum in the healing process of COVID-19 patients

Comparison of the Effectiveness of COVID-19 specific antibody in hyper-immune bovine milk & colostrum with ordinary bovine milk & colostrum on reducing the need for hospitalization and improving clinical symptoms of patients with COVID-19 that are taken care of in home.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200927048849N3
Enrollment
600
Registered
2021-03-17
Start date
2021-03-20
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 viral pneumonia. Pneumonia due to SARS-associated coronavirus

Interventions

Intervention 1: Intervention group: Referred COVID-19 patients to clinic of Alzahra hospital after explaining the study and obtaining consent the will be given twice a day, morning and evening 150 cc

Sponsors

Isfahan university
Lead Sponsor
Zeitoon Isfahan Vaccine Innovators Company
Collaborator
Biotechnology Investment Support Fund
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Infected patients of COVID-19 based on positive Polymerase Chain Reaction test Lack of hospitalization indication based on country protocol O2 Saturation more than 93% on the first visit Respiratory rate more than 24 on the first visit Age more than 18 years old Filling and signing of consent form A maximum of 10 days have elapsed since the onset of disease symptoms

Exclusion criteria

Exclusion criteria: Patients with immunodeficiency based on biography Lactose intolerance based on biography Uncontrollable vomiting Using antiviral drugs Pregnancy Failure to fill out the consent form Receiving immunosuppressive drugs

Design outcomes

Primary

MeasureTime frame
Need of Hospitalization during the next 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call.;Need to go to the emergency room during 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call.;No fever and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call.;No cough and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call.;No shortness of breath and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call.;No muscular pain and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call.;Mortality rate during 28 days after beginning of the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call.;ICU need during 28 days after beginning the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Niliahmadabadi

Virus research center of Isfahan university

nili@shirazu.ac.ir+98 31 3261 6334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026