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-20R) ● 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.

Related papers

No related papers found yet.

Interventions

DRUGMETFORMIN

DRUGCOLCHICINE

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-20R) ● 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 PAS	—

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-20R) ● 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 PAS

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Countries

Netherlands

Outcome results

None listed