Study to investigate treatment of pediatric participants with COVID-19

• Research type

  Research Study

• Full title

  A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

• IRAS ID

  1005109

• Contact name

  Jennifer Hammond

• Contact email

  Jennifer.Hammond@pfizer.com

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2022-000075-39

• Clinicaltrials.gov Identifier

  NCT05261139

• Research summary

  The purpose of the study is to find out if PF 07321332 (nirmatrelvir) co-packaged with ritonavir which is the study drug, helps treat non hospitalised symptomatic children with COVID-19 who are at risk of their COVID 19 infection getting worse. On 31 December 2021, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Paxlovid (nirmatrelvir and ritonavir) a conditional marketing authorisation for use after it was found to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.
  The study duration is up to 5 weeks. The study drug will be given in addition to the current medical treatment participants are receiving for COVID-19. The study drug should be taken every 12 hours for 5 days which will be a total of 10 doses. During some study visits, participants will be asked to provide biological samples (such as blood, urine, or nasal secretions from the back of the nose and throat) and undergo procedures that might be different from a regular medical examination. After they have completed 10 doses of study drug and completed the study Day 4 and Day 5 visits, participants health will continue to be assessed during 5 follow up study visits over the course of approximately 4 weeks. These visits may be conducted remotely.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  22/HRA/0558

• Date of REC Opinion

  4 May 2022

• REC opinion

  Further Information Favourable Opinion