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This study evaluates a therapeutic biologic mix (the NOVAVAX COVID-19 vaccine combined with the BCG vaccine, given through the skin/percutaneously) as a proof-of-concept in patients who have controlled cancers and moderate COVID-19. It enrolled adults with RT-PCR-confirmed, moderate COVID-19 whose cancer is under control. The trial is in Early Phase 1 and is active but not currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers. * 20 Moderate COVID-19 patients with controlled cancers Inclusion Criteria: * Controlled Cancers * Moderate COVID-19 * Positive testing by standard RT-PCR assay or equivalent testing * Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion * Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute * No clinical signs indicative of Severe or Critical Illness Severity Exclusion Criteria: * 1\. Uncontrolled Cancers * 2\. Severe or Critical Illness Severity * 3\. Pregnancy * 4\. Breast-feeding * 5\. The patients with other serious inter-current illness * 6\. Serious Allergy * 7\. Serious Bleed Tendency * 8\. The prohibition of the biological product