A Phase 2 interventional study of Mesenchymal stem cell and Placebo in SARS-CoV-2 Infection( COVID-19 ), sponsored by Rohto Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Rohto Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
Among 75 studies in COVID-19 with a site in Japan — 10 open to participants now, 11 under way, 8 of them phase 3. COVID-19 · Japan.
Among the 75 studies in COVID-19 with a site in Japan, this one is the 59th largest by enrollment of the 59 interventional ones that give a count, is one of 22 that started in 2021, is one of 5 in phase 2, and was the 35th registered.
7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →10 of the 75 studies in COVID-19 with a site in Japan are open now. Recruiting first, the newest first:
Shionogi · Sites in Japan, United States, Bulgaria
Ages 12+
Shionogi · Sites in Japan
Ages 12–74
Pfizer · Sites in Japan, United States, Argentina and 15 more countries
Ages 18+
Pfizer · Sites in Japan, United States, Argentina and 16 more countries
Ages 12+
Merck Sharp & Dohme LLC · Sites in Japan, United States, Argentina and 21 more countries
Ages 18+
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 19 · Phase 3 40 · Phase 4 1
First in 2016; this study’s year is marked. 22 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 102 across 4,365 interventional studies indexed under COVID-19.
Median enrollment 602 across the 59 interventional studies, 3,346 across the 15 observational. Of the 58 that completed or were terminated, 36 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
61 of 75 have an industry lead sponsor. The 10 most frequent:
Rohto Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Rohto Pharmaceutical Co., Ltd. has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
5 of the studies in COVID-19 with a site in Japan that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07746544Phase 3ShionogiStudy of Secutrelvir in Participants With COVID-19 | 2027-07-31 |
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07739446Chiba UniversityEffect of Surgical Masks in Preventing Acute Respiratory Infections | 2027-03 |
Add all 5 to your calendar (.ics) → With an account.
Among the 75 studies in COVID-19 with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
4 times dose of Mesenchymal stem cell
Biological: Mesenchymal stem cell
Saline
Biological: Placebo
1\*10\^8 cells are administered once a week, total four times intravenously.
Commercially available saline.
Ventilator Free Days
Ventilator Free Days which appear in subjects with ADR-001 treatment are evaluated.
Time frame: Day 28
Ran from Jun 2021 to primary completion in May 2023, 23 months.
Of 223 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's 23 months is above that.
Counting every sponsor, half of 582 studies reached it within 9 months; a quarter within 5 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesenchymal Stem Cell
Rohto Pharmaceutical Co., Ltd.