Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT05848427
Eligibility Criteria:
Inclusion Criteria: (1) admission to hospital, (2) fulfills WHO case definition, including a positive PCR for COVID-19 from any specimen (e.g., nasopharyngeal, throat, saliva, urine, stool, other bodily fluid), (3) not received any therapy (radiotherapy, chemotherapy, corticotherapy, hormonotherapy, immunotherapy, anti-inflammatory, antibiotics, antiparasitic, antiviral, antibacterial, convalescent plasma, monoclonal antibodies, or other treatments such as hydroxychloroquine and azithromycin) before admission and samples' collection, and (4) Spo2 \< 90%.
Exclusion Criteria: (1) Non-SARS-CoV-2, (2) active indication and use for one of the investigational products (e.g., HIV positive if antiretroviral agents were used), (3) allergy or hypersensitivity to one of the investigational products (Lopinavir/Ritonavir, Remdesivir, Tocilizumab) or other contraindication, (4) progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments, (5) received any therapy (radiotherapy, chemotherapy, hormonotherapy, immunotherapy, anti-inflammatory, antibiotics, antiparasitic, antiviral, antibacterial, convalescent plasma, monoclonal antibodies, or other treatments such as hydroxychloroquine and azithromycin) before admission and samples' collection, (6) weight loss during the last 2 years, (7) abdominal surgeries, (8) pregnancy, and (9) SpO2 superior or equal to 90%, and (10) vaccinated individuals were excluded.
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Sex:
ALL
Study:
NCT05848427
Study Brief:
Protocol Section:
NCT05848427