The aim of the study is to analyze whether the administration of a vaccine against COVID19 infection can reduce the symptoms of long COVID.

Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the COMIRNATY vaccine (COVID-19 mRNA vaccine, Pfizer-BioNTech) in people with long COVID

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003331-28-ES

Enrollment

776

Registered

2021-06-21

Start date

2021-07-29

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Unlike what happens with other respiratory viruses, in a significant proportion of patients who have suffered from the disease, general and multi-organ symptoms may persist for months, which has been called long COVID

Interventions

Trade Name: Comirnaty Pharmaceutical Form: Concentrate for solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults (=18 years) admitted for COVID-19 who continue with moderate or severe symptoms collected in the “COVID-19 Symptom Questionnaire” three months after hospital discharge and who sign the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 776 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Patients who have received any dose of any of the COVID-19 vaccines. -Contraindication for the COMIRNATY vaccine according to the technical data sheet. -Women who are pregnant or intend to become pregnant during the next three months after the administration of the vaccine.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of symptoms that persist three months after the acute phase of COVID.;Secondary Objective: -To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of the different general and organic symptoms that persist three months after the acute phase of COVID. -To evaluate the effect of the COMIRNATY vaccine on the quality of life of people with long COVID. -To evaluate the safety of the COMIRNATY vaccine in people with long COVID.;Primary end point(s): Change in the global score of the “COVID-19 Symptom Questionnaire” at week 12 after the administration of the second dose of COMIRNATY vaccine;Timepoint(s) of evaluation of this end point: The primary end point will be analyzed 12 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.	—

Measure

Time frame

Main Objective: To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of symptoms that persist three months after the acute phase of COVID.;Secondary Objective: -To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of the different general and organic symptoms that persist three months after the acute phase of COVID. -To evaluate the effect of the COMIRNATY vaccine on the quality of life of people with long COVID. -To evaluate the safety of the COMIRNATY vaccine in people with long COVID.;Primary end point(s): Change in the global score of the “COVID-19 Symptom Questionnaire” at week 12 after the administration of the second dose of COMIRNATY vaccine;Timepoint(s) of evaluation of this end point: The primary end point will be analyzed 12 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.

—

Secondary

Measure	Time frame
Secondary end point(s): -Change in the global score of the “COVID-19 Symptom Questionnaire” at week 24 and 48 after the administration of the second dose of COMIRNATY vaccine. -Change in the score of each one of the “symptomatic areas” of the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine: general, respiratory / thoracic symptoms, digestive, otorhinolaryngological and neuropsychiatric. -Change in the score of each of the symptoms in the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine. -Change in the score on the anxiety, depression and quality of sleep scales at week 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine. -Change in the score in the WHOQOL-Bref quality of life questionnaire at weeks 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine. -Proportion of symptoms that improve, do not change, or worsen at weeks 12, 24, and 48 after the second dose of COMIRNATY vaccine is administered. -Proportion of patients who develop clinical and laboratory adverse events at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine.;Timepoint(s) of evaluation of this end point: The secondary end points will be analyzed 12, 24 or 48 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.	—

Measure

Time frame

Secondary end point(s): -Change in the global score of the “COVID-19 Symptom Questionnaire” at week 24 and 48 after the administration of the second dose of COMIRNATY vaccine. -Change in the score of each one of the “symptomatic areas” of the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine: general, respiratory / thoracic symptoms, digestive, otorhinolaryngological and neuropsychiatric. -Change in the score of each of the symptoms in the “COVID-19 Symptom Questionnaire” at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine. -Change in the score on the anxiety, depression and quality of sleep scales at week 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine. -Change in the score in the WHOQOL-Bref quality of life questionnaire at weeks 12, 24 and 48 after the administration of the second dose of the COMIRNATY vaccine. -Proportion of symptoms that improve, do not change, or worsen at weeks 12, 24, and 48 after the second dose of COMIRNATY vaccine is administered. -Proportion of patients who develop clinical and laboratory adverse events at weeks 12, 24 and 48 after the administration of the second dose of COMIRNATY vaccine.;Timepoint(s) of evaluation of this end point: The secondary end points will be analyzed 12, 24 or 48 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.

—

Countries

Spain

Contacts

Public ContactÁrea de Ensayos Clínicos

FISABIO

rodenas_van@gva.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026