RECLAIM: an Adaptive Platform Trial for the Evaluation of Treatments for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Conditions

PASC: post-acute sequelae of SARS-CoV-2 infection

Brief summary

Assessed at 12 weeks (end of trial product use period): Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary score

Detailed description

Assessed at 12 weeks: ● PROMIS-29 mental health summary score ● PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance., Assessed at 12 weeks: ● Checklist Individual Strength (CIS-8) ● DePaul Symptom Questionnaire (DSQ-2) PEM questions ● PROMIS cognitive function 8a ● DSQ-2 POTS questions, Assessed at 12 weeks: ● Frequency of related and unrelated (S)AEs in each IP arm compared to its control arm including their severity and outcome., Assessed at 12 weeks: ● Level of adherence to each IP versus the matching placebo control (if available). ● Percent of participants with adequate adherence for the specific IP., Assessed at 24 weeks (12 weeks after cessation of IP use): The proportion of participants that maintain HRQoL treatment success at 12 weeks., Exploratory: Same as above but stratified by phenotype., Exploratory: Same as above but stratified by pre-enrolment PASC symptom(s) duration., Exploratory: Described in relevant TSAs., Exploratory: Described in relevant TSAs.

Janneke H. H. M. van de Wijgert, J M H Schoevers, Todd D. Swarthout, Wietske J. T. Bouwman, Joost van Rosmalen et al. (14 authors)

Trials2026-02-19

10.1186/s13063-026-09570-1

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMETFORMIN

DRUGCOLCHICINE

DRUGMINOCYCLINE

DRUGPlacebo tablets are identical to active minocycline tablets and will be relabelled identical to the study drug. Placebo tablets will have the same composition

DRUGexcept for the active substance. (microcrystalline cellulose

DRUGmagnesium stearate).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessed at 12 weeks (end of trial product use period): Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary score	—

Secondary

Measure	Time frame
Assessed at 12 weeks: ● PROMIS-29 mental health summary score ● PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance., Assessed at 12 weeks: ● Checklist Individual Strength (CIS-8) ● DePaul Symptom Questionnaire (DSQ-2) PEM questions ● PROMIS cognitive function 8a ● DSQ-2 POTS questions, Assessed at 12 weeks: ● Frequency of related and unrelated (S)AEs in each IP arm compared to its control arm including their severity and outcome., Assessed at 12 weeks: ● Level of adherence to each IP versus the matching placebo control (if available). ● Percent of participants with adequate adherence for the specific IP., Assessed at 24 weeks (12 weeks after cessation of IP use): The proportion of participants that maintain HRQoL treatment success at 12 weeks., Exploratory: Same as above but stratified by phenotype., Exploratory: Same as above but stratified by pre-enrolment PASC	—

Measure

Time frame

Assessed at 12 weeks: ● PROMIS-29 mental health summary score ● PROMIS-29 domain scores: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance., Assessed at 12 weeks: ● Checklist Individual Strength (CIS-8) ● DePaul Symptom Questionnaire (DSQ-2) PEM questions ● PROMIS cognitive function 8a ● DSQ-2 POTS questions, Assessed at 12 weeks: ● Frequency of related and unrelated (S)AEs in each IP arm compared to its control arm including their severity and outcome., Assessed at 12 weeks: ● Level of adherence to each IP versus the matching placebo control (if available). ● Percent of participants with adequate adherence for the specific IP., Assessed at 24 weeks (12 weeks after cessation of IP use): The proportion of participants that maintain HRQoL treatment success at 12 weeks., Exploratory: Same as above but stratified by phenotype., Exploratory: Same as above but stratified by pre-enrolment PASC

—

Countries

Netherlands

Outcome results

None listed