NCT04445506

Brief Summary

The investigators reviewed the charts of SARS-CoV-2 patients with pneumonia and moderate to severely elevated CRP and worsening hypoxemia who were treated with early, short-term dexamethasone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
Last Updated

June 24, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

June 19, 2020

Last Update Submit

June 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect on transfers to ICU and escalation of care needing mechanical ventilation

    2 months

Secondary Outcomes (2)

  • Effect on length of stay

    2 months

  • Change in CRP levels

    2 months

Study Arms (1)

SARS-CoV2 patients that received dexamethasone

Drug: Dexamethasone

Interventions

4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.

SARS-CoV2 patients that received dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients aged 18 years and older with positive SARS-CoV2 test with CRP greater than 50 mg/L and having greater than 2L Oxygen requirement

You may qualify if:

  • Moderate disease with at least a 30% increase in CRP within 36 hours of admission, and with increasing oxygen requirements.
  • All patients with severe disease with evidence of escalating oxygen requirements
  • The presence of secondary bacterial infections as a probable cause of increasing CRP levels was excluded in all selected patients.
  • Pulmonary embolism and /or cardiac dysfunction were excluded as probable causes of worsening hypoxia in all selected patients.

You may not qualify if:

  • All patients on other treatment modalities- Remdesivir and/or Convalescent plasma who showed evidence of clinical improvement as per decrease in CRP levels and/or oxygen requirements were excluded.
  • Patient with associated COPD exacerbation who would benefit from the use of steroids.
  • Patients with Diabetic ketoacidosis, hyperglycemic hyperosmolar state, active concurrent bacterial infections.
  • Patients with history of steroid-induced mania and/or psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Kwame Dapaah-Afriyie, MD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 24, 2020

Study Start

April 1, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

June 24, 2020

Record last verified: 2020-05

Locations