Trial Outcomes & Findings for Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia (NCT NCT04339179)

NCT ID: NCT04339179

Last Updated: 2024-10-15

Results Overview

Hospitalized suspected COVID-19 participants were monitored for at least 7-14 days after enrollment. Laboratory tests such as blood culture, RDT Influenza, RDT Dengue, Tubex TF, serology, and molecular were done to identify the etiology.

• Recruitment status: COMPLETED
• Target enrollment: 185 participants
• Primary outcome timeframe: at least 7-14 days after enrolment
• Results posted on: 2024-10-15

Participant Flow

Enrolment period was from November 2020 through July 2022. The study was done at 2 hospitals in Indonesia.

Participant milestones

Measure	Suspected COVID-19 Cases Hospitalized participants with suspected COVID-19
Overall Study STARTED	185
Overall Study COMPLETED	185
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

Baseline characteristics by cohort

Measure	Suspected COVID-19 Cases n=185 Participants Hospitalized participants with suspected COVID-19
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	175 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	185 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Indonesia	185 Participants n=5 Participants

PRIMARY outcome

Timeframe: at least 7-14 days after enrolment

Hospitalized suspected COVID-19 participants were monitored for at least 7-14 days after enrollment. Laboratory tests such as blood culture, RDT Influenza, RDT Dengue, Tubex TF, serology, and molecular were done to identify the etiology.

Outcome measures

Measure	Suspected COVID-19 Cases n=185 Participants Hospitalized participants with suspected COVID-19
Confirm Etiologies Among Suspected COVID-19 Cases SARS CoV-2	151 Participants
Confirm Etiologies Among Suspected COVID-19 Cases Other pathogens:	21 Participants
Confirm Etiologies Among Suspected COVID-19 Cases Unidentified pathogens	13 Participants

Adverse Events

Suspected COVID-19 Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Publication Division

INA-RESPOND

Phone: +62214208693

Email: inapublikasi@ina-respond.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place