NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study

NCCAPS is a longitudinal prospective cohort study designed to assess patient, disease and treatment factors associated with short- and long-term outcomes in patients with cancer who develop COVID-19. We also aimed to describe COVID-19 symptoms and treatments, and to describe disruptions in cancer treatment due to COVID-19. The study enrolled patients with cancer on active treatment or with a history of stem cell transplant or CAR-T cell therapy with new, active COVID-19, defined as being within 14 days of their first positive SARS-CoV-2 test. The study found that receipt of chemotherapy and baseline history of stroke, atrial fibrillation or pulmonary embolism were associated with a higher risk of hospitalization for COVID-19. Vaccination for SARS-CoV-2 was associated with a lower risk of hospitalization. Death due to COVID-19 was highest in patients with lymphoma, intermediate in those with acute leukemia and lung cancer, and lowest in those with other solid tumors and other hematologic cancers. Disruptions of cancer treatment were frequent in the first 30 days after SARS-CoV-2 infection.]]>
Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) and cancer treatment that fits into one of the three following categories: Metastatic (Stage IV) solid tumor, any hematologic malignancy, or any CNS malignancy, and: Patient is receiving eligible active treatment (defined as current treatment or treatment within the 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment. Eligible active treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy. OR Non-metastatic (Stage I-III) solid tumor and: Patient is receiving eligible active treatment (defined as current treatment or treatment within past 6 weeks prior to their first positive SARS-CoV-2 test collection) or is expected to begin receiving treatment within 2 weeks of study enrollment. Eligible active treatment types for non-metastatic solid tumor patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy (except as noted below). HER2-targeted therapy (trastuzumab, pertuzumab, neratinib, ado-trastuzumab) that is not accompanied by chemotherapy is NOT considered an eligible active treatment. Patients on endocrine therapy alone are not eligible. OR Prior or current transplant for the treatment of cancer: Patient has received an allogenic stem cell/bone marrow transplant or CAR-T cell or other modified cellular therapy at any time; or Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease; or Patient has received an autologous stem cell/bone marrow transplant within the past 2 years. Patient must have documented positive viral test result for SARS-CoV-2. For patients 18 years of age or older, the specimen collection for the patient's FIRST positive test must have occurred no earlier than 14 days prior to enrollment. For patients under 18 years of age, the specimen collection for the patient's first positive test must have occurred after January 31, 2020. The viral test can be either a nucleic acid (PCR) test or an antigen test. Serological or antibody tests are not allowed. Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test. Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again. The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance with the most recent guidance issued by the FDA in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. This policy is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised. NOTE: HIV-infected patients are eligible. Patients with CNS metastases are eligible. Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed.]]>
The study opened to enrollment in May 2020 and closed in February 2022. 2048 patients were screened and 1778 adult patients enrolled during this time period. After exclusions for negative SARS-CoV-2 testing, lack of receipt of a qualifying cancer-directed therapy, longer than 14 days between positive SARS-CoV-2 test and enrollment, data quality, and withdrawal of consent, 1572 adult patients were included in the analysis. Data analysis took place between September 2024 and April 2025.]]>