International SARS-CoV-2 Infection Observational Study (ICOS)
Tahapan Penelitian : Initial
Sponsor:
• Center for Research and Development of Health Resources and Services, National Institute of Health Research and Development (NIHRD), Indonesia, University of Minnesota (UMN) and The National Institute of Allergy and Infectious Diseases, National Institutes of Health/ NIH United States
Mitra Pelaksana:
INA-RESPOND, RSUP dr. Wahidin SUdirohusodo dan RSUPN Dr.Cipto Mangunkusumo
No Registry
INA-2GHFOKN
Tanggal Input Registry : 26-10-2020
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 27-10-2020 |
| Outcome Primer | 1. Estimate the rate of hospitalization or death during the 28-day follow-up period. 2. Identify risk factors for hospitalization or death. |
| Outcome Skunder | 1. Estimate the proportion of screened adults who test positive for SARS-CoV-2. 2. Compare characteristics between those who test virus positive versus those who test negative for the global cohort and by geographic region: o demographics o co-morbid conditions or immunosuppression o risk factors for death from COVID-19. |
| Descriptive Information | |
| Judul Penelitian Popular | International SARS-CoV-2 Infection Observational Study (ICOS) |
| Judul Penelitian Ilmiah | International SARS-CoV-2 Infection Observational Study (ICOS) |
| Jenis Penelitian | Observational |
| Intervensi | Tidak ada Intervensi |
| Jumlah Subyek Penelitian | 500 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. ≥ 18 years of age. 2. Not hospitalized. 3. Signed informed consent.Exclusion Criteria: Persons with a known positive SARS-CoV-2 test > 28 days ago. |
| Administrative Information | |
| Nomor Persetujuan Etik | (NIHRD-IRB) Komisi Etik Penelitian Kesehatan Badan Penelitian dan Pengembangan Kesehatan: No. LB.02.01/2/KE.520/2020 tertanggal 10 Agustus 2020 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | INSIGHT-011 ICOS |
| Contact Person | Dr. Muhammad Karyana, M.Kes; National PI: Prof. dr. Pratiwi P. Sudarmono, Ph.D.,SpMK(K) |