Effects of the treatment with the anti-inflamatory medication AP1189 on the lung involvement in COVID-19 patients with impaired breathing.

Effects of the administration of AP1189, a pro resolutive pathways up regulator, on lung alterations of COVID-19 patients and impaired oxygenation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-59447vn

Enrollment

Unknown

Registered

2021-05-29

Start date

2020-12-18

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Severe acute respiratory syndrome

Interventions

AP1189, 100mg once daily during fasting. The mode of administration will be orally or through a nasoenteral catather if needed. The predicted duration of the treatment is 14 days. Six patients will be

D26.371

11350

Eligibility

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Male and female subjects, 18 to 85 years of age hospitalized with COVID-19 infection; Written informed consent; Confirmed COVID-19 by the presence of SARS-CoV-2 nucleic acid by polimerase chain reaction; Pregnancy is excluded or unlikely (reliable contraception/post-menopausal women).

Exclusion criteria

Exclusion criteria: Progress to death is imminent and unavoidable in the opinion of the investigator; Participating in other clinical trials (except in COVID-19 antiviral drug trials); Any condition that in the view of the screening physician suggests that the patient is unable to comply with study procedures; Subjects treated with immunosuppressive drugs; HIV infection; Pregnant women or breastfeeding mothers; Estimated glomerular filtration rate less than 30ml/min; Severe liver disfunction (Child-Pugh score C); Medical history of oral glucocorticoid treatment (Exception is COVID-19 dexamethasone treatment not exceeding 10mg/day).

Design outcomes

Primary

Measure	Time frame
Days until respiratory recovery. The O2 saturation will be measured twice daily for all patients by a fingertip pulse oximeter. Primary outcome is achieved when O2 saturation is equal or grater than 93% in room air.	—

Secondary

Measure	Time frame
Recovery/death. After 28 days the patient is approached and it is determined if recovery was achieved of in the deceased by any cause.;Length of hospital stay. The number of days that the patient spends in the hospital are counted.;Ventilator free days. Every day the patient spends with invasive mechanical ventilation is counted. Ventilator free days are calculated by subtracting the number of days on the ventilator from 28.	—

Measure

Time frame

Recovery/death. After 28 days the patient is approached and it is determined if recovery was achieved of in the deceased by any cause.;Length of hospital stay. The number of days that the patient spends in the hospital are counted.;Ventilator free days. Every day the patient spends with invasive mechanical ventilation is counted. Ventilator free days are calculated by subtracting the number of days on the ventilator from 28.

—

Countries

Brazil

Contacts

Public ContactMauro Teixeira

mmtex.ufmg@gmail.com55-31-999945133

Outcome results

None listed

Source: REBEC (via WHO ICTRP)