Trial Outcomes & Findings for RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms (NCT NCT05595369)
NCT ID: NCT05595369
Last Updated: 2025-12-02
Results Overview
Appendix-specific outcome measure data will be reported under the associated NCT ID.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
963 participants
Primary outcome timeframe
90 days
Results posted on
2025-12-02
Participant Flow
This is a platform study record. Study recruitment period was from late July 2023 to mid-August 2024 at 69 US sites. Recruiting centers were a mix of large academic and small independent research sites in rural and urban, outpatient settings.
Consented participants were required to endorse two moderate or one severe symptom in one of 3 symptom clusters (exercise intolerance, autonomic dysfunction, or cognitive dysfunction), then meet or exceed a minimal score on a symptom specific questionnaire prior to being assigned. In addition to platform protocol inclusion and exclusion, participants had to meet no symptom cluster exclusion criteria and meet all drug appendix inclusion criteria and no drug appendix exclusion criteria.
Participant milestones
| Measure |
Experimental: Paxlovid 25 Day Dosing
Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 25 day dosing: Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
Experimental: Paxlovid 15 Day Dosing
Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 15 day dosing: Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
|
Placebo Comparator: Control
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Placebo Comparator: Control: Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
|---|---|---|---|
|
Overall Study
STARTED
|
323
|
320
|
320
|
|
Overall Study
COMPLETED
|
304
|
297
|
304
|
|
Overall Study
NOT COMPLETED
|
19
|
23
|
16
|
Reasons for withdrawal
| Measure |
Experimental: Paxlovid 25 Day Dosing
Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 25 day dosing: Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
Experimental: Paxlovid 15 Day Dosing
Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 15 day dosing: Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
|
Placebo Comparator: Control
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Placebo Comparator: Control: Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
10
|
10
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
6
|
|
Overall Study
Did Not Meet Eligibility Criteria
|
0
|
4
|
0
|
|
Overall Study
Study Drug Non-compliance
|
0
|
1
|
0
|
|
Overall Study
Moved Out of State Unexpectedly
|
0
|
1
|
0
|
Baseline Characteristics
RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
Baseline characteristics by cohort
| Measure |
Experimental: Paxlovid 25 Day Dosing
n=321 Participants
Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 25 day dosing: Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
Experimental: Paxlovid 15 Day Dosing
n=312 Participants
Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 15 day dosing: Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
|
Placebo Comparator: Control
n=318 Participants
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Placebo Comparator: Control: Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
Total
n=951 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 13.77 • n=121 Participants
|
48.8 years
STANDARD_DEVIATION 13.89 • n=122 Participants
|
47.1 years
STANDARD_DEVIATION 14.31 • n=243 Participants
|
48.4 years
STANDARD_DEVIATION 14.01 • n=24 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
217 Participants
n=121 Participants
|
209 Participants
n=122 Participants
|
212 Participants
n=243 Participants
|
638 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
103 Participants
n=121 Participants
|
102 Participants
n=122 Participants
|
106 Participants
n=243 Participants
|
311 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Undifferentiated
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Unknown
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=121 Participants
|
33 Participants
n=122 Participants
|
44 Participants
n=243 Participants
|
108 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
288 Participants
n=121 Participants
|
277 Participants
n=122 Participants
|
272 Participants
n=243 Participants
|
837 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
13 Participants
n=243 Participants
|
41 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=121 Participants
|
31 Participants
n=122 Participants
|
37 Participants
n=243 Participants
|
109 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
244 Participants
n=121 Participants
|
254 Participants
n=122 Participants
|
249 Participants
n=243 Participants
|
747 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
8 Participants
n=243 Participants
|
26 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
10 Participants
n=243 Participants
|
25 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
321 Participants
n=121 Participants
|
312 Participants
n=122 Participants
|
318 Participants
n=243 Participants
|
951 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Enrolled participants.
Appendix-specific outcome measure data will be reported under the associated NCT ID.
Outcome measures
| Measure |
Experimental: Paxlovid 25 Day Dosing
n=323 Participants
Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 25 day dosing: Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
Experimental: Paxlovid 15 Day Dosing
n=320 Participants
Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
Experimental: Paxlovid 15 day dosing: Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)
|
Placebo Comparator: Control
n=320 Participants
Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
Placebo Comparator: Control: Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)
|
|---|---|---|---|
|
Total Number of Participants Enrolled in Each Appendix
|
323 Participants
|
320 Participants
|
320 Participants
|
Adverse Events
Experimental: Paxlovid 25 Day Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Paxlovid 15 Day Dosing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Comparator: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place