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Randomized adaptive assessment of post COVID syndrome treatments (RAPID) Reducing Inflammatory Activity in Patients with post COVID Syndrome (REVIVE)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511628-16-00
Acronym
2023-02978
Enrollment
376
Registered
2024-05-31
Start date
2024-07-18
Completion date
2025-09-30
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Covid Syndrome (PCS)

Brief summary

Intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from Baseline to Day 56

Detailed description

Intra-patient change in overall mental and physical health as measured by the SF-36-PF; from Baseline to Days 28, 56 and 84, Intra-patient change from Baseline to Days 28, 56 and 84 in a. Intensity of fatigue and incapacitation measured by the FSS b. Severity of mental disorder symptoms such as depression, anxiety, somatization, and distress measured by the PHQ modules PHQ-9, GAD-7, PHQ-15, and PHQ-stress, Intra-patient change from Baseline to Days 28 and 56 in Cognitive function measured by the MoCa, Intra-patient change from Baseline to Days 28, 56 and 84 in a. Severity of dyspnea, measured by the mMRC b. PEM frequency, strength and severity as measured by the PEM questionnaire c. Intra-patient change from Baseline to Days 28 and 56 in orthostatic/autonomic dysfunction measured by the PST d. Physical exercise capacity, measured as the change in number of repetitions during the 1MSTST, Intra-patient change from Baseline to Days 28 and 56 in a. Physical activity parameters: global activity (steps/24h), wear time (min), time spent in physical activity (min), resting (bpm) and activity heart rate bpm) b. Autonomic function parameters: heart rate turbulence, nocturnal heart rate, nocturnal respiratory rate, expiration-triggered sinus arrhythmia, baroreflex sensitivity, frequency of spontaneous ectopic beats measured by use of mhealth devices

Interventions

DRUGThe placebo tablets contain mycrocrystalline cellulose as a filler
DRUGcrospovidone EP Type A as desintegrant and magnesium stearate as lubricant

Sponsors

Goethe University Frankfurt
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Intra-patient change in physical function as measured by the Short Form-36 Physical Function (SF-36-PF) from Baseline to Day 56

Secondary

MeasureTime frame
Intra-patient change in overall mental and physical health as measured by the SF-36-PF; from Baseline to Days 28, 56 and 84, Intra-patient change from Baseline to Days 28, 56 and 84 in a. Intensity of fatigue and incapacitation measured by the FSS b. Severity of mental disorder symptoms such as depression, anxiety, somatization, and distress measured by the PHQ modules PHQ-9, GAD-7, PHQ-15, and PHQ-stress, Intra-patient change from Baseline to Days 28 and 56 in Cognitive function measured by the MoCa, Intra-patient change from Baseline to Days 28, 56 and 84 in a. Severity of dyspnea, measured by the mMRC b. PEM frequency, strength and severity as measured by the PEM questionnaire c. Intra-patient change from Baseline to Days 28 and 56 in orthostatic/autonomic dysfunction measured by the PST d. Physical exercise capacity, measured as the change in number of repetitions during the 1MSTST, Intra-patient change from Baseline to Days 28 and 56 in a. Physical activity parameters: global ac

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026