Infections, CoronavirusNCT04542226

Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19

An observational study of Infections, Coronavirus, run by NPO Petrovax at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Infections, Coronavirus
What is being tested?: Polyoxidonium
Type of treatment: Injection or infusion
How many people: 81 participants
Where: 5 sitesin 2 countries
Study dates: 31 Mar 2020to 30 Oct 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: Hospitalized adult patients with verified diagnosis of COVID-19 administered Polyoxidonium, according to the instruction for its medical usage in complex with Russian MoH guidance for treatment of COVID-19

Who may be able to join

The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
Verified coronavirus disease COVID-19, and at least one of the following:
severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (SpO2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute,
mild-moderate disease: SpO2 > 94% on room air or respiratory rate < 24 breaths per minute.
The patient signed an Informed Consent form for participation in this study.
The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
Male and female patients from 18 years of age.
Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen prior to inclusion.

Who cannot join

Pregnancy or breastfeeding.
Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
Participation in any clinical study within 30 days before the Informed Consent form provided.
Hypersensitivity and/or intolerability to any ingredient of the investigational product.
Acute or chronic renal failure.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Russia4 sites

State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic
Cheboksary, Chuvashskaya Respublika, 428017
State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital"
Novaya Usman', Voronezh Oblast, 396310
State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai
Novorossiysk, Krasnodarskiy Kray, 353915
State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital"
Yoshkar-Ola, Mari El Republic, 424005

Other trials in Russia

Belarus1 site

Healthcare Institution "Grodno Regional Infectious Clinical Hospital"
Grodno, 230030

Other trials in Belarus

About this study

Official title: Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19

Read the detailed description

The study was planned as an observation of Polyoxidonium® administered in addition to Russian Ministry of Healthcare (MoH) guidance for standard COVID-19 treatment. Regimens have no limitations to the use of concomitant therapy. The aim of the study is to observe the safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections, 12 mg in addition to complex treatment of hospitalized patients with COVID-19.

Conditions: Infections, Coronavirus
Being tested: Polyoxidonium
Medical subject headings: Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PolyoxidoniumDrug
Also called azoximer bromide
Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)

Study groups in NCT04542226
Study group	Role	What they receive
Adult patients hospitalized with COVID-19		Patients eligible for enrollment into the study Receives: Drug: Polyoxidonium

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Status of the Patient (According to 7-point Ordinal Scale)
Subject clinical status using the 7-point Ordinal Scale, specified as the primary endpoint in the WHO Master Protocol on day 15 as compared to baseline
(1 - Not hospitalized, no limitations on activities; 2 - Not hospitalized, limitation on activities; 3 - Hospitalized, not requiring supplemental oxygen; 4 - Hospitalized, requiring supplemental oxygen; 5 - Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 7 - Death).
Measured: Day 1 (Baseline), Day 15

Secondary outcomes (8)

Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score
Ordinal scale (OS) score status, time to improvement by 1 point for each OS score.
Subject clinical status using the 7-point Ordinal Scale:
1. - Not hospitalized, no limitations on activities;
2. - Not hospitalized, limitation on activities;
3. - Hospitalized, not requiring supplemental oxygen;
4. - Hospitalized, requiring supplemental oxygen;
5. - Hospitalized, on non-invasive ventilation or high flow oxygen devices;
6. - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation;
7. - Death.
Measured: Days 1 - 29.
Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))
NEWS scale score status, time to a discharge from a hospital or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
NEWS score is based on 7 clinical parameters:
respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, temperature. A score of 0, 1, 2, 3 is allocated to each parameter except supplemental oxygen (a score 0 or 1 is allocated) and level of consciousness (a score 0 or 3 is allocated). A higher score means the parameter is further from the normal range. All scores were summed to get an aggregate score. Aggregate score ranges from 0 to 19, with higher scores meaning higher risk.
Low risk - aggregate score, 1-4 Low to medium risk - score 3 in any single parameter, Medium risk - aggregate score 5-6, High risk - aggregate score 7-19.
Measured: Days 1 - 29.
Number of Patients Requiring Supplementary Oxygen
Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29
Measured: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.
Hospitalisation Duration
Duration of hospitalisation
Measured: Days 1 - 29
Mortality
Number of participants who were dead or alive (Days 1 - 29)
Measured: Days 1 - 29.
The Number of Participants With Serious Adverse Events
The number of participants with serious adverse events (SAE)
Measured: Days 1 - 29.
The Number of Participants With Adverse Events
The number of participants with adverse events (AE)
Measured: Days 1 - 29.
Number of Participants With Discontinuation of Drug Administration
Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events
Measured: Days 1 - 17.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202030 Oct 2020

First posted9 Sep 2020
Study start31 Mar 2020
Primary completion15 Jul 2020
Study completion30 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infections, CoronavirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04542226
Sponsor's protocol ID: Covid_v_1.0
Status last verified: Dec 2020
First submitted: 8 Sep 2020
Last updated: 9 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infections, Coronavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19
ClinicalTrials.gov ID: NCT04542226
Acronym / sponsor ID: Covid_v_1.0
Conditions: Infections, Coronavirus
Study type: Observational
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: NPO PetrovaxIndustry (pharma, biotech, devices)
Study start: 31 Mar 2020 (actual)
Primary completion: 15 Jul 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 9 Sep 2020 (actual)
Results: Posted 3 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adult patients hospitalized with COVID-19	–	Drug: PolyoxidoniumPatients eligible for enrollment into the study

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Hospitalized adult patients with verified diagnosis of COVID-19 administered Polyoxidonium, according to the instruction for its medical usage in complex with Russian MoH guidance for treatment of COVID-19

Key inclusion criteria (8 listed)

The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
Verified coronavirus disease COVID-19, and at least one of the following:
The patient signed an Informed Consent form for participation in this study.
The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
Male and female patients from 18 years of age.

Key exclusion criteria (5 listed)

Pregnancy or breastfeeding.
Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
Participation in any clinical study within 30 days before the Informed Consent form provided.
Hypersensitivity and/or intolerability to any ingredient of the investigational product.
Acute or chronic renal failure.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PolyoxidoniumAlso: azoximer bromidePolyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)	Drug	Adult patients hospitalized with COVID-19

Primary outcome

Clinical Status of the Patient (According to 7-point Ordinal Scale)
Time frame: Day 1 (Baseline), Day 15
Subject clinical status using the 7-point Ordinal Scale, specified as the primary endpoint in the WHO Master Protocol on day 15 as compared to baseline (1 - Not hospitalized, no limitations on activities; 2 - Not hospitalized, limitation on activities; 3 - Hospitalized, not requiring supplemental oxygen; 4 - Hospitalized, requiring supplemental oxygen; 5 - Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 7 - Death).

8 secondary outcomes

Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score
Time frame: Days 1 - 29.
Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))
Time frame: Days 1 - 29.
Number of Patients Requiring Supplementary Oxygen
Time frame: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.
Hospitalisation Duration
Time frame: Days 1 - 29
Mortality
Time frame: Days 1 - 29.
The Number of Participants With Serious Adverse Events
Time frame: Days 1 - 29.
The Number of Participants With Adverse Events
Time frame: Days 1 - 29.
Number of Participants With Discontinuation of Drug Administration
Time frame: Days 1 - 17.

Results and safety

Results posted to the registry on 3 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Patients Hospitalized With COVID-19	81	81

Primary outcome: Clinical Status of the Patient (According to 7-point Ordinal Scale)

Time frame: Day 1 (Baseline), Day 15. Count of participants. Unit: Participants

Measure	Adult Patients Hospitalized With COVID-19 n = 81
Number of patients at Baseline (Day 1): 1. Not hospitalized, no limitations on activities	0
Number of patients at Baseline (Day 1): 2. Not hospitalized, limitation on activities	0
Number of patients at Baseline (Day 1): 3. Hospitalized, not requiring supplemental oxygen	22
Number of patients at Baseline (Day 1): 4. Hospitalized, requiring supplemental oxygen	24
Number of patients at Baseline (Day 1): 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices	24
Number of patients at Baseline (Day 1): 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation	11
Number of patients at Baseline (Day 1): 7. Death	0
Number of patients on Day 15: 1. Not hospitalized, no limitations on activities	3

Adult Patients Hospitalized With COVID-19: p <0.0000001, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety parameters were evaluated throughout the study in the Safety population (SAP; patients who received at least one Polyoxidonium dose, according to the prescribed treatment) from signing the informed consent to the study completion visit on Day 29±3.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Patients Hospitalized With COVID-19	1 of 81 (1.2%)	6 of 81 (7.4%)	0 of 81

Limitations and caveats (from the sponsor): There was no control or comparison group, polyoxidonium was used in the treatment of all patients, it is not possible to compare the results of treatment of patients with and without Polyoxidonium. The study used various treatment regimens for COVID-19 (antiviral agents, antimalarial agents, anticoagulants), depending on the base of the study, so it is impossible to fully determine whether these agents influenced the effectiveness of Polyoxidonium.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nikolay S. Dodonov study chair

NPO Petrovax

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infections, Coronavirus, run by NPO Petrovax at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Status of the Patient (According to 7-point Ordinal Scale) (time frame: Day 1 (Baseline), Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.