Acute Respiratory Tract InfectionPhase 3NCT04346693

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19

A Phase 3 study testing Standard therapy recommended by the Ministry of Health of the Russian Federation., Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection and Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation in people with Acute Respiratory Tract Infection and Acute Respiratory Insufficiency, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to evaluate an effectiveness of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms associated with severe and critical coronavirus infection cases (SARS COVID19, expanded as Severe acute respiratory syndrome Cоrona… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Respiratory Tract Infection, Acute Respiratory Insufficiency, Pneumonia
What is being tested?: Standard therapy recommended by the Ministry of Health of the Russian Federation., Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection and Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteRussia
Study dates: 8 Apr 2020to 20 Nov 2020
Phase: Phase 3
Are there results?: None posted in the registry

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients from the age of 18 years male and female;
Coronavirus infection confirmed by results of Polymerase chain reaction test;
Hospitalization of the patient;
The presence of a signed informed consent to participate in the study.

Who cannot join

Revocation of informed consent by the patient.
Patient mismatch inclusion criteria.
First identified conditions and / or diseases described in the non-inclusion criteria.
The criteria for early termination of patient participation in the study during the period of use of the study drug are:
Patient withdrawal of informed consent.
First identified conditions and / or diseases described in the non-inclusion criteria.

Show all 12Show fewer

The occurrence of serious adverse events.
Adverse events that do not meet the criteria of severity, the development of which, according to the researcher, further participation in the study may be detrimental to the health or well-being of the patient.
Administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as gross protocol violations that may affect the results of the study.
The patient receives / needs additional treatment that may affect the outcome of the study or patient safety
Individual intolerance to research drugs
Incorrect inclusion (for example, the patient was included in violation of the criteria for inclusion / non-inclusion of the protocol)

Trial locations and contacts

1 site in 1 country.

Russia1 site

Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, 123098

Other trials in Russia

About this study

Official title: An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)

Test drugs that will be administered to patients are:

Leitragin, solution for inhalation administration,
Dalargin, solution for intravenous and intramuscular administration.

Read the detailed description

Research objectives are:

To study the effectiveness of the drug Leitragin, a solution for inhalation, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Leitragin, a solution for inhalation, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19).

Upon admission to a specialized hospital for all patients with suspected COVID-19 Polymerase chain reaction (PCR) is being conducted. Only patients with confirmed coronavirus infection are included in the study.

It is an open, randomized clinical trial of the drug Dalargin in combination with Leitragin for the prevention and treatment of severe pulmonary complications symptoms in patients with coronavirus infection (SARS-COVID-19)

Conditions: Acute Respiratory Tract Infection, Acute Respiratory Insufficiency, Pneumonia, Septic Shock, Hypoxemia
Being tested: Standard therapy recommended by the Ministry of Health of the Russian Federation., Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection, Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation, Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation
Medical subject headings: Pneumonia, Shock, Septic, Hypoxia

What participants receive

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

Standard therapy recommended by the Ministry of Health of the Russian Federation.Procedure or surgery
Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injectionProcedure or surgery
Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalationProcedure or surgery
Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalationProcedure or surgery
Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.
Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days

Study groups in NCT04346693
Study group	Role	What they receive
group 1	Active comparator	80 patients with moderate and critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). Standard therapy is prescribed recommended by the Ministry of Health of the Russian Federation. Receives: Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.
group 2	Experimental	80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days). Receives: Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection
group 3	Experimental	80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional inhalation of the drug Leitragin, at a dose of 10 mg daily once a day until the symptoms of pulmonary complications will be ceased. Receives: Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation
group 4	Experimental	80 patients with moderate to critical severity of the disease with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular administration of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days) in conjunction with inhalation of the drug Leitragin, at a dose of 10 mg daily once a day until the symptoms of pulmonary complications will be ceased. Receives: Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation

What is being measured

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

The change of viral load in patients with SARS-COVID-19.
Estimated by Polymerase chain reaction (PCR)
Measured: Upon patient inclusion in the study, after 96 hours and on the 10day;
The frequency of development of Acute Respiratory Distress Syndrome (ADRS)
Assessed through the entire patient participation in the study
Measured: up to 10 days
Duration of hospitalization
The number of days a patient is hospitalized
Measured: up to 10 days
The frequency of early mortality
Early mortality from all causes will be estimated
Measured: up to 30 days
The frequency of late mortality
Late mortality from all causes will be estimated
Measured: up to 90 days
Clinical status at the time of completion of participation in the study
Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria:
1. Death;
2. Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation;
3. Hospitalization extended, on non-invasive ventilation;
4. Hospitalization is extended, needs additional oxygen;
5. Hospitalization is extended, additional oxygen is not required;
6. Discharged.
Measured: an average of 10 days

Timeline

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

8 Apr 202020 Nov 2020

First posted15 Apr 2020
Study start8 Apr 2020
Primary completion1 Nov 2020
Study completion20 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory Tract InfectionStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04346693
Sponsor's protocol ID: DAL-05-04-2020
Status last verified: Oct 2021
First submitted: 8 Apr 2020
Last updated: 13 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019

All Acute Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug for the Prevention and Treatment of Symptoms of Pulmonary Complications in Patients With Coronavirus Infection (SARS-COVID-19)
ClinicalTrials.gov ID: NCT04346693
Acronym / sponsor ID: DAL-05-04-2020
Conditions: Acute Respiratory Tract Infection, Acute Respiratory Insufficiency, Pneumonia, Septic Shock, Hypoxemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Burnasyan Federal Medical Biophysical CenterOther government
Study start: 8 Apr 2020 (actual)
Primary completion: 1 Nov 2020 (actual)
Study completion: 20 Nov 2020 (actual)
First posted: 15 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Test drugs that will be administered to patients are:

Leitragin, solution for inhalation administration,
Dalargin, solution for intravenous and intramuscular administration.

Detailed description

Research objectives are:

To study the effectiveness of the drug Leitragin, a solution for inhalation, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Leitragin, a solution for inhalation, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To study the effectiveness of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Leitragin, a solution for inhalation administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the prevention of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19);
To evaluate the safety and tolerability of the use of the drug Dalargin, a solution for intravenous and intramuscular administration, for the treatment of severe pulmonary complications in patients with coronavirus infection (SARS-COVID-19).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
group 1	Active comparator	Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation.80 patients with moderate and critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). Standard therapy is prescribed recommended by the Ministry of Health of the Russian Federation.
group 2	Experimental	Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome (ADRS). A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days).
group 3	Experimental	Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation80 patients with moderate to critical severity of the COVID19 with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional inhalation of the drug Leitragin, at a dose of 10 mg daily once a day until the symptoms of pulmonary complications will be ceased.
group 4	Experimental	Procedure: Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation80 patients with moderate to critical severity of the disease with respiratory symptoms without Acute Respiratory Distress Syndrome. A standard concomitant therapy will be given recommended by the Ministry of Health of the Russian Federation, with the additional intramuscular administration of the drug Dalargin (solution for intravenous and intramuscular doses of 1 mg once a day for 10 days) in conjunction with inhalation of the drug Leitragin, at a dose of 10 mg daily once a day until the symptoms of pulmonary complications will be ceased.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients from the age of 18 years male and female;
Coronavirus infection confirmed by results of Polymerase chain reaction test;
Hospitalization of the patient;
The presence of a signed informed consent to participate in the study.

Key exclusion criteria (12 listed)

Revocation of informed consent by the patient.
Patient mismatch inclusion criteria.
First identified conditions and / or diseases described in the non-inclusion criteria.
The criteria for early termination of patient participation in the study during the period of use of the study drug are:
Patient withdrawal of informed consent.

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
Standard therapy recommended by the Ministry of Health of the Russian Federation.Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course. For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered. For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days	Procedure or surgery	group 1
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injectionHydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course. For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered. For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days. Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days	Procedure or surgery	group 2
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalationHydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course. For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered. For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days. Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.	Procedure or surgery	group 3
Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalationHydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course. For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered. For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days. Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased. Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days	Procedure or surgery	group 4

Primary outcome

The change of viral load in patients with SARS-COVID-19.
Time frame: Upon patient inclusion in the study, after 96 hours and on the 10day;
Estimated by Polymerase chain reaction (PCR)
The frequency of development of Acute Respiratory Distress Syndrome (ADRS)
Time frame: up to 10 days
Assessed through the entire patient participation in the study
Duration of hospitalization
Time frame: up to 10 days
The number of days a patient is hospitalized
The frequency of early mortality
Time frame: up to 30 days
Early mortality from all causes will be estimated
The frequency of late mortality
Time frame: up to 90 days
Late mortality from all causes will be estimated
Clinical status at the time of completion of participation in the study
Time frame: an average of 10 days
Clinical status at the time of completion of participation in the study will be estimated based upon the following criteria: 1. Death; 2. Hospitalization is extended, on invasive mechanical ventilation of the lungs with extracorporeal membrane oxygenation; 3. Hospitalization extended, on non-invasive ventilation; 4. Hospitalization is extended, needs additional oxygen; 5. Hospitalization is extended, additional oxygen is not required; 6. Discharged.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
Individual participant dataSharing planned: No

Related trials for Acute Respiratory Tract Infection

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingObservational study
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute Respiratory Infection, Acute Respiratory Tract Infection
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 12 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The change of viral load in patients with SARS-COVID-19. (time frame: Upon patient inclusion in the study, after 96 hours and on the 10day;). The study lists 6 primary outcomes in all. 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 NCT04346693.

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 13 Oct 2021.