Protective Effect of Aspirin on COVID-19 Patients

NCT04365309 | Unknown Phase 2

• 1 other identifier: Xi jingH
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 has a high infection rate and mortality, and serious complications such as heart injury cannot be ignored. Cardiac dysfunction occurred in COVID-19 patients, but the law and mechanism of cardiac dysfunction remains unclear. The occurrence of progressive inflammatory factor storm and coagulation dysfunction in severe and fatal cases of NCP points out a new direction for reducing the incidence of severe and critically ill patients, shortening the length of duration in severe and critically ill patients and reducing the incidence of complications of cardiovascular diseases. Aspirin has the triple effects of inhibiting virus replication, anticoagulant and anti-inflammatory, but it has not received attention in the treatment and prevention of NCP. Although Aspirin is not commonly used in the guidelines for the treatment of NCP, it was widely used in the treatment and prevention of a variety of human diseases after its first synthesis in 1898. Subsequently, aspirin has been confirmed to have antiviral effect on multiple levels. Moreover, one study has confirmed that aspirin can inhibit virus replication by inhibiting prostaglandin E2 (PGE2) in macrophages and upregulation of type I interferon production. Subsequently, pharmacological studies have found that aspirin as an anti-inflammatory and analgesic drug by inhibiting cox-oxidase (COX). Under certain conditions, the platelet is the main contributor of innate immune response, studies have found that in the lung injury model in dynamic neutrophil and platelet aggregation. In summary, the early use of aspirin in covid-19 patients, which has the effects of inhibiting virus replication, anti-platelet aggregation, anti-inflammatory and anti-lung injury, is expected to reduce the incidence of severe and critical patients, shorten the length of hospital duration and reduce the incidence of cardiovascular complications.

Conditions

Novel Coronavirus Pneumonia; Aspirin; Treatment

Keywords

Novel coronavirus pneumonia; Aspirin; Protective effect

Outcome Measures

Primary Outcomes (2)

• clinical recovery time (TTCR)

  TTCR is defined as the study treatment (oral aspirin enteric-coated tablet) began to fever, breathing rate, blood oxygen saturation recovery, and cough relieving for at least 72 hours.

  not more than 14 days

• the time of SARS-CoV2 overcasting

  Time of SARS-CoV2 in upper respiratory tract specimens overcasting detected by RT-PCR.

  not more than 37 days

Study Arms (2)

the NCP standard treatment group

NO INTERVENTION

According to the diagnosis and treatment guidelines, the patients were divided into four types: mild, common, severe and critically ill. Then patients with common and severe ill were randomly divided into two groups, respectively, namely the NCP standard treatment group and the NCP aspirin group (aspirin 100 mg/d, oral + combined standard treatment).

the NCP aspirin treatment group

EXPERIMENTAL

According to the diagnosis and treatment guidelines, the patients were divided into four types: mild, common, severe and critically ill. Then patients with common and severe ill were randomly divided into two groups, respectively, namely the NCP standard treatment group and the NCP aspirin group (aspirin 100 mg/d, oral + combined standard treatment). Patients in the NCP aspirin group were given aspirin 100 mg/d orally after admission and aspirin for 14 days after discharge.

Drug: Aspirin 100mg

Interventions

Aspirin 100mg DRUG

on the bases of standard treatment for the COVID-19, low-dose aspirin (100 mg/ day), orally，is added to.

Also known as: Oxygen therapy, antiviral treatment and other support treatments

the NCP aspirin treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteered to participate in the study, approved the aspirin treatment, and was willing to randomly accept one of the aspirin treatment regimens, and provided written informed consent,
• Subject is required to meet one of the following criteria for confirmation of a novel coronavirus infection with pneumonia: 1.The 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,
• 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;
• Agree not to participate in another study until completion of the 14-day study; If you need to withdraw from this study;
• The subjects had not taken aspirin for nearly one month prior to the screening period.
• Can follow the study or follow up procedure. -

You may not qualify if:

• 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, organized pneumonia, etc.
• Patients with cardiac stent placement (\< 1 year).
• Any more complex medical problems that may interfere with research behavior or lead to increased risk, such as malignant tumors, blood diseases, liver diseases, AIDS, viral hepatitis, etc.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Cai Yue

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Fischer AL, Messer S, Riera R, Martimbianco ALC, Stegemann M, Estcourt LJ, Weibel S, Monsef I, Andreas M, Pacheco RL, Skoetz N. Antiplatelet agents for the treatment of adults with COVID-19. Cochrane Database Syst Rev. 2023 Jul 25;7(7):CD015078. doi: 10.1002/14651858.CD015078.

  PMID: 37489818 DERIVED

MeSH Terms

Interventions

Aspirin; Oxygen

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Cai Yue

  the first affiliated hospital of the Air force medical university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: February 10, 2020
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-03

Locations

CN (1)