Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVI… (NCT04412395) | Clinical Trial Compass
UnknownPhase 2
Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease
Egypt516 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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…