Table 2.
Clinical trials investigating the effects of drugs targeting the PI3K/Akt/mTOR pathway in COVID-19.
| Trial | Status | Last update | Estimated enrolment | Study start date | Intervention/treatment | Placebo comparator |
|---|---|---|---|---|---|---|
| NCT04371640: Safety and tolerability of Sirolimus adjuvant therapy in patients with COVID-19 | Withdrawn (study population not regularly admitted to hospital; approaches have shifted away from repurposing old drugs) | December 7, 2020 | 0 | May 1, 2020 | Sirolimus + standard medical care Day 1: 10 mg; Days 2–7: 5 mg | Placebo + standard medical care Day 1: 10 ml Days 2–7: 5 ml |
| NCT04341675: Effect of sirolimus in improving clinical outcomes in hospitalized patients with COVID-19 | Recruiting | May 20, 2020 | 30 participants | April 24, 2020 | Sirolimus 6 mg daily on Day 1 followed by 2 mg daily for next 13 days for total treatment duration of 14 days or hospital discharge, whatever happens sooner | Matching placebo + standard medical care |
| NCT04461340: The efficacy and safety of sirolimus as an adjuvant agent to the standard treatment protocol in patients with COVID-19 infection | Recruiting | September 9, 2020 | 40 participants | August 15, 2020 | 20 patients will receive sirolimus (oral dose of 6 mg on Day 1 followed by 2 mg daily for 9 days) plus national standard-of-care therapy against COVID-19; daily administration of sirolimus (1 mg) for up to 4 weeks while hospitalized | Matching placebo + standard medical care |
| NCT04482712: The clinical effectiveness of mTOR inhibition with rapamycin in minimizing or decreasing the ALI/ARDS in participants infected with mild to moderate COVID-19 infection | Withdrawn (study was never submitted to IRB or approved because of feasibility issues) | June 1, 2021 | 20 participants | April 2021 | Administration of rapamycin (sirolimus) 1 mg daily during hospitalization | Matching placebo + standard medical care |
| NCT04374903: The clinical improvement in COVID-19 Patients treated with Hydroxychloroquine in Combination with Azithromycin or Sirolimus.: | Not yet recruiting | May 5, 2020 | 58 participants | May 1, 2020 | Subjects will receive either HCQ with azithromycin (AZ) or HCQ with sirolimus (SIR). Study A: subjects will receive HCQ 600 mg orally for 10 days and AZ 250 mg orally daily for 10 days; study B: subjects will receive HCQ 600 mg orally for 10 days and SIR 4 mg orally on Day 1, then 2 mg orally daily for 9 days | Matching placebo + standard medical care |
| NCT04409327: Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults (≥65 years) Residing in Nursing Homes | Terminated (insufficient accrual rate) | February 10, 2021 | 36 participants | July 11, 2020 | Oral RTB101 (TORC1 inhibitor) 10 mg hard gelatin capsule once daily for 4 weeks | Oral-matching placebo once daily for 4 weeks |
| NCT04584710: A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults (≥65 years) | Active, not recruiting | February 9, 2021 | 60 participants | October 13, 2020 | Oral RTB101 (TORC1 inhibitor) 10 mg hard gelatin capsule once daily for 2 weeks | Oral matching placebo once daily for 2 weeks |
| NCT04372602: The efficacy of the PI3K inhibitor Duvelisib in improving the overall survival and advanced disease manifestations of SARS-CoV-2 infection | Recruiting | May 25, 2021 | 28 participants | October 12, 2020 | Duvelisib 25 mg twice daily for up to 10 days | Placebo 25 mg twice daily for up to 10 days |