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Protective Effect of Aspirin on COVID-19 Patients (PEAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365309
Recruitment Status : Enrolling by invitation
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.


Condition or disease Intervention/treatment Phase
Novel Coronavirus Pneumonia Aspirin Treatment Drug: Aspirin 100mg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protective Effect of Aspirin on COVID-19 Patients
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
No Intervention: the NCP standard treatment group
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).
Experimental: the NCP aspirin treatment group
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
on the bases of standard treatment for the COVID-19, low-dose aspirin (100 mg/ day), orally,is added to.
Other Name: Oxygen therapy, antiviral treatment and other support treatments




Primary Outcome Measures :
  1. clinical recovery time (TTCR) [ Time Frame: not more than 14 days ]
    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.

  2. the time of SARS-CoV2 overcasting [ Time Frame: not more than 37 days ]
    Time of SARS-CoV2 in upper respiratory tract specimens overcasting detected by RT-PCR.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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,
  2. 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,
  3. Chest image confirmed pulmonary involvement;
  4. 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;
  5. Onset time ≤14 days;
  6. Agree not to participate in another study until completion of the 14-day study; If you need to withdraw from this study;
  7. The subjects had not taken aspirin for nearly one month prior to the screening period.
  8. Can follow the study or follow up procedure. -

Exclusion Criteria:

  1. Women who have recently been pregnant or breast-feeding.
  2. Having a history of active gastrointestinal bleeding in the past 3 months.
  3. Blood routine examination showed that the platelet count was < 30×109/L.
  4. Patients with coagulation disorders.
  5. Unable to understand the potential risks and benefits of the study, and unable to follow up the evaluation as required.
  6. Having no capacity for civil conduct.
  7. A history of drug or alcohol abuse.
  8. Allergic to aspirin.
  9. Influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial lung virus, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia, organized pneumonia, etc.
  10. Patients with cardiac stent placement (< 1 year).
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365309


Locations
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China, Shaanxi
Cai Yue
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Cai Yue the first affiliated hospital of the Air force medical university
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT04365309    
Other Study ID Numbers: Xi jingH
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
Novel coronavirus pneumonia
Aspirin
Protective effect
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics