ORCHID (INA-107) : INA-RESPOND Observational Research on Infectious Disease Outbreaks & Difficult Cases of Unidentified Etiology in Indonesia; COVID-19 Pandemic

ClinicalTrials.gov: NCT04339179
Collaborator: NIAID, NIH
Status: Completed

https://clinicaltrials.gov/study/NCT04339179

The ORCHID observational study was originally designed to prospectively investigate infections of unknown etiology during outbreaks and in challenging hospitalization cases, with a focus on emerging and re-emerging diseases. The study was quickly repurposed during the COVID-19 pandemic to focus on patients hospitalized with suspected SARS-CoV-2 infection. From November 2020 to July 2022, 185 adults were enrolled and followed for at least 14 days. All participants provided blood, respiratory swabs, urine, faeces, and saliva for on-site and centralized testing, including SARS-CoV-2 rapid diagnostic test, RT-PCR, and serology; acid-fast bacilli smear; blood culture; typhoid rapid diagnostic test; influenza rapid diagnostic test; and dengue rapid diagnostic test, RT-PCR, and serology. Among the participants, 152 had SARS-CoV-2, including 2 with concurrent dengue infection. Other detected pathogens included dengue (4), M. tuberculosis (1), influenza A and B (3, 1), respiratory syncytial virus (1), and Haemophilus influenzae type B and non-type B (1, 6). Only 61 (33.3%) participants had received at least one dose of a COVID-19 vaccine before enrollment, mostly (72.1%) from Sinovac, and 5 (2.7%) participants on the study died.

orchid 2
ORCHID SITES Ver 2 (1)

Associated Biorepository

Specimen Type Baseline Follow up (7-14 days)
COVID-19 Positive COVID-19 Negative COVID-19 Positive COVID-19 Negative
Plasma EDTA 148 32 N/A N/A
Buffy Coat 121 30 N/A N/A
Serum 149 32 137 11
Swab (NP) in VTM 149 32 139 10
Swab (OP) in VTM 149 32 139 10
Urine 137 30 103 7
Stool 95 18 44 3
Saliva 116 25 86 7
Specimen Type Visit Variant*
Delta        Omicron    Other
AY.23  AY.24 B.1.617.2 BA.1 BA.1.1 BA.1.13.1 B.1 B.1.1.398  B.1.459 B.1.466 B.1.466.2
Plasma EDTA Enroll. 13 5 3 1 2 5 1 7 5 12 34
Buffy Coat Enroll. 13 5 3 1 2 5 1 0 0 11 28
Serum Enroll. 13 5 3 1 2 5 1 8 5 12 34
Day 7-14 12 3 3 1 1 4 1 8 5 12 34
Urine Enroll. 13 5 3 1 2 5 1 8 4 10 30
Day 7-14 12 3 3 1 1 2 1 6 3 10 28
Faeces Enroll. 9 4 1 1 1 2 1 5 4 8 18
Day 7-14 3 1 2 0 0 1 1 3 3 7 8
Saliva Enroll. 12 4 3 1 2 3 1 7 2 10 23
Day 7-14 12 2 3 0 0 1 1 4 1 9 26
Swab (NP) in VTM Enroll. 13 5 3 1 2 5 1 8 5 12 34
Day 7-14 13 3 3 1 1 4 1 8 5 12 34
Swab (OP) in VTM Enroll. 13 5 3 1 2 5 1 8 5 12 34
Day 7-14 13 3 3 1 1 4 1 8 5 12 34
*Sequencing data are available for 89 participants (submitted to GISAID).  Accession IDs are EPI_ISL_19750669 to EPI_ISL_19750753, and EPI_ISL_19761433 to EPI_ISL_19761436.