Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease

• Status: Not yet recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to clinically use bovine Lf as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID-19 patients. The study was approved by the ethical committee of the Egyptian Center for Research and Regenerative Medicine in 11-5-2020.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Center, Egypt; National Research Centre, Egypt
• Collaborator: Egyptian Military Medical Services
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• Patients tested positive (PCR) for SARS-CoV-2 and clinically symptomatic.

• Adult patients with age >18 years.

• Patients willing and able to sign the study informed consent form.

Exclusion Criteria:

• Critically severe disease patients (having Respiratory failure requiring mechanical ventilation, or signs of septic shock or multiple organ failure requiring ICU admission).

• Patients who are unconscious

• Patients who have convulsions

• Patients suffering from central cyanosis with SPO2< 90% (for asthmatic patients with SPO2<88%)

• Pregnant or lactating women

• Patients with a known history of pro-inflammatory diseases (patients with autoimmune diseases, patients receiving chemotherapy for cancer, patients with malabsorption, patients with inflammatory bowel disease, Crohn's disease or ulcerative colitis).

• History or suspected immunosuppressive or immunodeficient state including HIV infection, or chronic immunosuppressant medication (more than 14 days) within the past 3 months (inhaled and topical steroids are allowed).

• Patients with severe renal impairment (GFR <60 ml/min/1.73m2 as measured by the Cockcroft-Gault formula).

• Patient with severe hepatic impairment, biliary cirrhosis or cholestasis

• Patients who received immunoregulatory therapy within one month before the start of the study.

• Patients with Known or suspected allergy or any contraindications to Lactoferrin.

• Any condition, according to the judgment of the investigator, would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.