NCT04422470

Brief Summary

This is an observational prospective cohort study to evaluate the clinical course and outcomes of COVID-19 and the underlying disease in patients with hematologic disease (malignant or non-malignant).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
666

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

15 active sites

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

First Submitted

Initial submission to the registry

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

June 8, 2020

Last Update Submit

January 25, 2023

Conditions

Keywords

COVID-19Blood diseasesLeukemiaLymphoma

Outcome Measures

Primary Outcomes (1)

  • 30-day all-cause mortality

    Rate of death from any cause

    30 day

Secondary Outcomes (6)

  • COVID-19 complications

    30 day

  • ICU admission

    30 day

  • Mechanical ventilation / O2 requirement

    30 day

  • Relapse or progression of hematologic disease

    30 day, 90 day and 180 day

  • Overall survival

    30 day, 90 day and 180 day

  • +1 more secondary outcomes

Interventions

Non-interventional study

Eligibility Criteria

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

Patients with hematologic disease (both malignant and non-malignant) infected with SARS-CoV-2

You may qualify if:

  • Age 18 or older
  • Any previously or currently diagnosed hematologic disease
  • Laboratory confirmed or suspected (based on clinical symptoms and/or CT) COVID-19
  • Known outcome of COVID-19 in case of retrospective data input (protocol allows retrospective data input for patients who were prospectively followed in local centers)

You may not qualify if:

  • Loss of follow-up within 30 days after COVID-19 diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Republican Clinical Hospital of Tatarstan

Kazan', Russia

Location

City Hospital n.a. V.V. Veresaev

Moscow, Russia

Location

Clinical Hospital n.a. S.P. Botkin

Moscow, Russia

Location

N.V. Sklifosovsky Emergency Institute

Moscow, Russia

Location

National Research Center for Hematology

Moscow, Russia

Location

Regional Clinical Hospital N.A. Semashko

Nizhny Novgorod, Russia

Location

Regional Hospital

Novosibirsk, Russia

Location

Regional Clinical Hospital

Omsk, Russia

Location

RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

Saint Petersburg, 197022, Russia

Location

Republican Clinical Hospital No4

Saransk, Russia

Location

Republic Clinical Hospital n.a. N.A. Semashko

Ulan-Ude, Russia

Location

Regional Clinical Hospital

Vladimir, Russia

Location

Regional Clinical Hospital No2

Vladivostok, Russia

Location

Regional Clinical Hospital

Yaroslavl, Russia

Location

Regional Clinical Hospital No1

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Coronavirus InfectionsHematologic DiseasesCOVID-19LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsHemic and Lymphatic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elena Parovichnikova

    National Research Center for Hematology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 9, 2020

Study Start

June 22, 2020

Primary Completion

August 22, 2021

Study Completion

January 18, 2022

Last Updated

January 26, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations