Cohort study of human mpox virus disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Oxford

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

2 Aug 2022 → 31 Jan 2024

Decision date (initial)

2022-08-02

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

To describe clinical outcomes in patients with mpox virus disease treated and not treated with tecovirimat (or other antiviral drugs)

Secondary objectives 3

1. To describe other clinical outcomes in patients with mpox virus disease treated and not treated with tecovirimat (or other antiviral drugs).
2. To describe virological outcomes in patients with mpox virus disease treated or not treated with tecovirimat (or other antiviral drugs).
3. To describe safety outcomes in patients with mpox virus disease treated with tecovirimat (or other antiviral drugs).

Conditions and MedDRA coding

Monkeypox virus disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. All patients, with either laboratory confirmed monkeypox virus disease OR Laboratory confirmation pending, but who are being managed as a presumptive case
2. Informed consent provided for participation in the study

Exclusion criteria 2

1. Presumptive cases with subsequent negative test for MPXV
2. Adults lacking capacity due to a previously present impairing condition

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to lesion(s) resolution, defined a.From a start point of date that positive test is collected (or that treatment started if any delayed treatment) b. Until an endpoint of up to 14 days since inclusion (or since commencement of treatment if any delayed treatment). c.Where lesion resolution is the first day on which all lesions are resorbed, scabbed or desquamated and mucosal ulcers healed. d.And the absence of any serious complications

Secondary endpoints 4

1. Clinical status defined by a) Clinical status on day 14 and day 28 according to an ordinal scale assessed by a physician or a study nurse. The ordinal scale is a) all lesions resolved and no serious complications, b) one or more lesions are active and no serious complications, c) serious complication and/or hospitalization due to mpox, or d) death. b) Evidence of recrudescence or relapse at day 60 and day 180.
2. Virological status defined by: A) Change from baseline in mpox virus DNA levels in throat swabs on days 4, 8, 14 and 28; B)Change from baseline in Monkeypox virus DNA levels in blood on days 4, 8, 14 and 28, C) Presence of Monkeypox virus DNA in lesion swabs on days 4, 8, 14 and 28.
3. In cohort receiving tecovirimat (or other antivirals): Number and type of Serious Adverse Events (SAEs), Suspected Adverse Reactions (SARS) and Suspected Unexpected Serious Adverse Reactions, (SUSARs) within 28 days of enrolment
4. Outcome of pregnancy in women who are pregnant

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Oxford

Sponsor organisation

University Of Oxford

Address

Boundary Brook House, Churchill Drive, Headington Churchill Drive Headington

City

Oxford

Postcode

OX3 7GB

Country

United Kingdom

Scientific contact point

Organisation

University Of Oxford

Contact name

ISARIC general enquiries

Public contact point

Organisation

University Of Oxford

Contact name

ISARIC general enquiries

Locations

8 EU/EEA countries · 76 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications