TRIPOD Study

We have submitted 2 papers from the TRIPOD study: #1 “The Characteristics of Drug Sensitive and Drug-Resistant Tuberculosis Cases in Indonesia” to the American Journal of Tropical Medicine and Hygiene on 22nd February 2022; and #2 “Performance of Xpert TB/RIF and Sputum Microscopy Compared to Sputum Culture for Diagnosis of Tuberculosis in Seven Indonesian Hospitals” to the Frontiers in Medicine-Infectious Diseases – Surveillance, Prevention, and Treatment on 31 March 2022. We just received comments from 1 reviewer for paper #2. Paper #1 is still under review.

The subculture isolates sent to Bandung BBLK are still ongoing, from 301 baseline samples 234 were done sub-culturing and the mTB DNA was extracted. Eight of them did not grow and the remaining 59 samples are in process.

RePORT Network call for abstracts to be presented in the upcoming Annual RePORT International meeting in Cape Town, South Africa, 7-8 September 2022 for Young Investigators. RePORT network will provide airfare, hotel expenses, as well as an invitation to participate in a poster discussion at the meeting. Young investigators defined as one of the following:

  • faculty members who are no more than five years out from completion of all training; current clinical fellows,
  • doctoral students or post-docs; or current medical students or residents.
  • completed their last degree by 2014 or after (not more than 8 years of completion).
  • The abstracts should be of high scientific quality and should describe work related to either the TRIPOD Protocol; in other words, any ongoing projects that leverage, or plan to leverage, the established RePORT platform.

PROACTIVE Study

As of May 17, 2022, from 4336 subjects enrolled, 46.1 % of the subjects have ended their study, and 53,09% of the subjects are still ongoing. The picture below shows the study progress from each Site.

For the end of study subjects, 1.838 subjects had already completed the study until follow up visit month 36, 233 subjects died, 162 subjects were lost to follow up, 32 subjects withdrew consent, 31 subjects moved to a city without a PROACTIVE site, five subjects with HIV negative, and one subject suspended (imprisoned). Detailed information for each site can be seen in the table below.

Below are the monitoring activities during April & May 2022:

  • 5th onsite monitoring visit to site 590 RSUP Persahabatan, Jakarta, 11-13 April 2022.
  • 5th onsite monitoring visit to site 580 RSUp Dr. Sardjito, Yogyakarta, 17-19 May 2022
  • 4th onsite monitoring visit to RSUD Abdul Wahab Sjah-ranie, Samarinda, 23-25 May 2022

Based on uploaded CRFs as of 10 May 2022, a total of 183 participants were enrolled in the ORCHID-COVID-19 study, with 115 from site 610 (RSU Kabupaten Tangerang, Tangerang) and 68 from site 521 (RS Universitas Uda-yana, Denpasar). This study had 172 (94%) participants who completed the visits, with 5 (3%) participants died during the study. In terms of deaths, 2 subjects from site 610 died because of COVID-19 and heart failure, while 3 subjects from site 521 died from thromboembolism, non-ST-segment Elevation Myocardial Infarction, and thromboembolism. On the other hand, 6 (3%) participants decided to not continue participation to the study (categorized as other) (figure 1).

As of 10 May 2022, a total of 153 (84%) participants were identified as positive COVID-19 while 30 (16%) participants were identified as negative COVID-19. In site 610, the number of participants identified as positive COVID-19 was 105 (91%) and 10 (9%) participants identified as negative COVID-19. On the other hand, in site 521, there were 48 (71%) participants identified as positive COVID-19 and 20 (29%) participants identified as negative COVID-19 (figure 2).

In site 521, SARS-CoV-2 was identified in 47 (69%) participants based on the pathogen identification data. SARS-CoV-2 and Dengue (confirmed by PCR SARS-CoV-2 and RDT Dengue IgM) co-infection were identified in 1 (1%) participant. Dengue (confirmed by RDT Dengue NS-1) was also identified in 3 (5%) participants. Based on the data from site 610, SARS-CoV-2 was identified in 103 (90%) participants. SARS-CoV-2 and dengue (confirmed by PCR SARS-CoV-2, RDT Dengue NS-1, and RDT Dengue IgM IgG) co-infection were identified in 2 (2%) participants. Influenza (confirmed by PCR) was identified in 2 (2%) participants. Dengue (confirmed by RDT Dengue NS-1 and RDT Dengue IgM IgG) was also identified in 1 (1%) participant. Overall, the pathogen was unidentifiable among 24 (13%) participants, 17 were from Site 521 and 7 from site 610 (figure 3).

The annual report for notifying study progress was submitted to local IRB RSU Kabupaten Tangerang on May 13, 2022. Since NIHRD IRB may not be able to receive a new/extension of ethical clearance, we will submit the annual report by the end of this month while preparing the submission to the other IRBs in parallel. The current ORCHID-COVID-19 study will continue to recruit additional patients. However, we plan to shift to the ORCHID general protocol when the preparation is finished.

Several calls with NIAID will be held to discuss manuscripts based on the ORCHID-COVID-19 study results. The analysis of data from the FluPRO questionnaire is of particular interest. The FluPRO preliminary analysis was presented and discussed with John Powers. In-puts will be factored into the analysis.