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. 2023 Jul 25;2023(7):CD015078. doi: 10.1002/14651858.CD015078

NCT04365309.

Study name Protective Effect of Aspirin on COVID‐19 Patients (PEAC)
Methods
  • Trial design: RCT, open‐label, phase 2 + 3

  • Type of publication: trial registry

  • Setting: Xijing Hospital

  • Recruitment dates: enrolling by invitation

  • Country: China

  • Language: English

  • Number of centres: NR

  • Inclusion criteria: meets one of the following criteria for confirmation of a novel coronavirus infection with pneumonia: 1. Detection of novel coronavirus nucleic acid is positive in respiratory or blood specimens by real‐time ‐PCR, 2. Virus gene sequencing of respiratory or blood specimen is highly homologous with known novel coronavirus; not taken aspirin for nearly one month prior to the screening period.

  • Exclusion criteria: women who have recently been pregnant or breast‐feeding, having a history of active gastrointestinal bleeding in the past 3 months, blood routine examination showed that the platelet count was < 30 × 109/L, patients with coagulation disorders, unable to understand the potential risks and benefits of the study, and unable to follow up the evaluation as required, having no capacity for civil conduct, a history of drug or alcohol abuse, allergic to aspirin, influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial lung virus, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia, organic pneumonia, etc., patients with cardiac stent placement (< 1 year), any more complex medical problems that may interfere with research behaviour or lead to increased risk, such as malignant tumours, blood diseases, liver diseases, AIDS, viral hepatitis, etc, chest image confirmed pulmonary involvement, fever: ≥ 36.7 ℃ under the armpit, ≥ 38.0 ℃ in the oral cavity or ≥ 38.6 ℃ in the rectum and eardrum; respiratory frequency ≥ 24 times/min or at least one cough, onset time ≤ 14 days

  • Trial registration number: NCT04365309

  • Date of trial registration: 28 April 2020

  • Prospective completion date: June 2020

Participants
  • Age: 18 to 85 years

  • Gender: NR

  • Ethnicity: NR

  • Number of participants (recruited/allocated/evaluated): 128/NR/NR

  • Severity of disease: SARS‐CoV‐2 infection (COVID‐19) (including mild, common, severe and critically ill)

  • Additional diagnoses: pneumonia

  • Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): NR

Interventions
  1. Patients in the NCP aspirin group were given aspirin 100 mg/d orally after admission and aspirin for 14 days after discharge

  2. Standard therapy

  • Concomitant therapy: NR

  • Treatment cross‐overs: NR

  • Duration of follow‐up: NR

  • Treatment cross‐overs: NR

  • Compliance with assigned treatment: NR

Outcomes Primary outcomes
  1. Clinical recovery time (TTCR)

  2. The time of SARS‐CoV‐2 overcasting


Secondary outcomes: NR
Additional outcomes: NR
Starting date 10 February 2020
Contact information NR
Notes
  • Sponsor/funding: Xijing Hospital

  • COIs: NR

  • Other: NR