P-Co-Li (Pulmonary Covid-19 Study)

NCT04782700 | Withdrawn

• 1 other identifier: IRB # 21-0076
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether the use of steroids versus watchful waiting improves pulmonary function tests in patients with history of COVID 19 infection who have residual hypoxemia and lung infiltrates. This is a non-inferiority trial which tests whether the outcomes after watchful waiting are not worst than after the use of steroids, with a margin of acceptable inferiority. The study team will limit inclusion to patients who have PCR- confirmed COVID19 at least in 10-weeks prior to enrollment, persistent opacities on chest imaging, and hypoxemia either at rest or during ambulation.

Conditions

Covid19; Lung Inflammation; Hypoxemic Respiratory Failure

Keywords

COVID19

Outcome Measures

Primary Outcomes (1)

• Worsened pulmonary function test (PFT) (FVC or DLCO)

  Worsened PFT (FVC (forced vital capacity) or DLCO (diffusing capacity of the lungs for carbon monoxide)) at or prior to12 weeks. (FVC stayed the same if normal, or worsened by \>10% OR DLCO worsened by \>15%; or if start rescue treatment without pft we will assume it's a failed pft)\*\*

  Baseline to 12-weeks

Secondary Outcomes (8)

• Hypoxemia

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

• 6 Minute-Walk Test (6MWT)

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

• mBorg Dyspnea Scale

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

• PROMIS Short Forms Outcomes Survey

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

• Lower Extremity Functional Scale

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

Other Outcomes (1)

• Changes in COVID19 bundle labs

  Baseline to 12 weeks; and 6, 12, 24 and 36-months

Study Arms (2)

Watchful Waiting

NO INTERVENTION

The patients randomized to the watchful waiting group will not be prescribed any steroids at the time of randomization.

Prednisone (Steroid) Taper

EXPERIMENTAL

The patients randomized to the steroid group will be prescribed prednisone PO or an equivalent corticosteroid at a dose of 0.5 mg/kg/day for 4 weeks ((plus BACTRIM-DS (1PO qd. 160/800mg) as prophylaxis against infection - If patient have a sulfa allergy, their physician will prescribe atovaquone 1500mg qd instead of Bactrim) and followed by a gradual taper of 0.25 mg/kg/day for 4 weeks, followed by 0.125 mg/kg qd for 4 weeks.

Other: Steroid Taper (Prednisone)

Interventions

Steroid Taper (Prednisone) OTHER

The patients randomized to the steroid group will be prescribed prednisone PO or an equivalent corticosteroid at a dose of 0.5 mg/kg/day for 4 weeks ((plus BACTRIM-DS (1PO qd. 160/800mg) as prophylaxis against infection - If patient have a sulfa allergy, their physician will prescribe atovaquone 1500mg qd instead of Bactrim) and followed by a gradual taper of 0.25 mg/kg/day for 4 weeks, followed by 0.125 mg/kg qd for 4 weeks.

Prednisone (Steroid) Taper

Eligibility Criteria

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

You may qualify if:

• Outpatients age\>18 with PCR positive COVID19 at least 4-weeks prior;
• persistent opacities (GGO and/or reticular changes) on any chest imaging at least 4-weeks after positive COVID PCR;
• HYPOXEMIA as defined by any of the below:
• Or patient already on supplemental oxygen
• Or room air saturation 94% or less

You may not qualify if:

• age \<18
• special populations (minors, pregnant women, decisional impairment which prevents them from making their own health decisions)
• subjects with underlying ILD pre-COVID19 infection

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Respiratory Insufficiency

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Negin Hajizadeh, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: April 1, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

US (1)