NCT04377607

Brief Summary

A rapid oxygen desaturation has observed in patients with COVID-19 which have seriously respiratory failure and most of them have intubated and connected to the mechanical ventilator. Finally, many of them have died during the process. ORF8 and superficial glycoproteins of a novel coronavirus bind to porphyrin on haemoglobin molecules and inhibit heme metabolism in an erythrocyte. However, it is not clarify the effects of the novel coronavirus on mean corpuscular volume (MCV), mean corpuscular of haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

19 days

First QC Date

May 4, 2020

Last Update Submit

September 13, 2020

Conditions

Keywords

coronavirushaemoglobin concentrationCOVID-19severity of disease

Outcome Measures

Primary Outcomes (1)

  • Relationship between severity of disease and values of erythrocyte indices

    The severity of disease can decrease haemoglobin concentration and destroy oxygen transport.

    5 days

Secondary Outcomes (1)

  • Sensitivity of haemoglobin concentration on severity of the disease

    5 days

Study Arms (3)

Group OP

outpatients with asymptomatic or uncomplicated or mild pneumonia

Other: File scanning

Group H

hospitalized patients

Other: File scanning

Group IC

patients admitted to intensive care unit

Other: File scanning

Interventions

RBC, HGB, HCT, MCH, MCV, MCHC, WBC values will be noted in the hemogram test performed at the time of initial admission

Group HGroup ICGroup OP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who applied to the hospital for a coronavirus disease symptom and whose covid-19 test was positive

You may qualify if:

  • All patients with COVID-19 test (+) using the PCR technique

You may not qualify if:

  • Those receiving blood products or any drugs that will affect their blood values before admission
  • Those patient with any hematologic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

November 1, 2020

Primary Completion

November 20, 2020

Study Completion

December 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations