SARS-CoV-2 InfectionPhase 2/3NCT04575064
An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
A Phase 2/3 study testing Remdesivir in people with SARS-CoV-2 Infection and COVID-19, run by Professor Dr. Bernd Mühlbauer at 4 sites in Germany.
Trial summary
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19, Moderate and Severe COVID-19
- What is being tested?
- Remdesivir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesGermany
- Study dates
- 29 Jun 2020to Nov 2022
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older
- Current SARS-CoV-2 infection
- Admitted to the hospital ward or the ICU due to COVID-19
- SpO2 <= 94% on room air OR oxygen demand OR breathing support
- Written informed consent obtained
Who cannot join
- Patient's non-consent or inability to informed consent
- Pregnant or breastfeeding women.
- Subjects pretreated with one of the study drugs in the past 29 days
- Anticipated transfer within 72 hours to a non-study hospital
- Severe co-morbidity with life expectancy < 3 months
- AST or ALT > 5 times the upper limit of normal
Show all 10Show fewer
- Stage 4 severe chronic kidney disease or requiring dialysis
- Contraindications and known intolerance to any of the study drugs
- Subjects participating in a potentially confounding drug or device trial
- Any reason why the patient should not participate (investigator's opinion)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Gesundheit Nord gGmbH
Bremen, 28211
Universitätsklinikum Gießen
Giessen, 35392
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
Technische Universität München (TUM)
München, 81675
About this study
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
- Conditions
- SARS-CoV-2 Infection, COVID-19, Moderate and Severe COVID-19
- Being tested
- Standard of Care (SoC), Remdesivir
- Medical subject headings
- COVID-19, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SoC)Other
Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.
RemdesivirDrug
Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SoC) | Other | This arm will receive standard supportive care according to guidelines for COVID-19. This is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients. Receives: Other: Standard of Care (SoC) |
| Remdesivir + SoC | Experimental | Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care Receives: Other: Standard of Care (SoC); Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
WHO 7-point ordinal scale:
- Not hospitalized, no limitations on activities;
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death
Measured: at day 15
Secondary outcomes (11)
Time to an improvement of one category from admission using the 7-point ordinal scale
Measured: up to 29 days
Mortality: 28 days mortality; in-house mortality
Measured: up to 29 days
Hospital stay: Duration of hospital stay due to COVID-19
Measured: up to 29 days
Oxygen: Need of, time to first receiving and duration of oxygen
Measured: up to 29 days
Intensive care: Need of, time to first receiving and duration of intensive care
Measured: up to 29 days
Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation
Measured: up to 29 days
ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation
Measured: up to 29 days
Superinfections, assessed with pathogen testing
Measured: up to 29 days
Kidney failure
Measured: up to 29 days
Myocardial failure
Measured: up to 29 days
Multiple organ failure
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start29 Jun 2020
- Primary completionMar 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Explanation will be submitted later.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Dr. Bernd Mühlbauer
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, World Health Organization
- Responsible party
- Sponsor-investigator, Professor Dr. Bernd Mühlbauer, Klinikum Bremen-Mitte, gGmbH
- Investigators
- Tobias Welte, MD, Prof., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575064
- Sponsor's protocol ID
- WHO-SOLIDARITY-GERMANY
- Other IDs
- 2020-001549-38
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2020
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
- ClinicalTrials.gov ID
- NCT04575064
- Acronym / sponsor ID
- WHO-SOLIDARITY-GERMANY
- Conditions
- SARS-CoV-2 Infection, COVID-19, Moderate and Severe COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Explanation will be submitted later.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Professor Dr. Bernd MühlbauerUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, World Health Organization
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 5 Oct 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.
This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SoC) | Other | Other: Standard of Care (SoC)This arm will receive standard supportive care according to guidelines for COVID-19. This is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients. |
| Remdesivir + SoC | Experimental | Other: Standard of Care (SoC), Drug: RemdesivirRemdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years and older
- Current SARS-CoV-2 infection
- Admitted to the hospital ward or the ICU due to COVID-19
- SpO2 <= 94% on room air OR oxygen demand OR breathing support
- Written informed consent obtained
Key exclusion criteria (10 listed)
- Patient's non-consent or inability to informed consent
- Pregnant or breastfeeding women.
- Subjects pretreated with one of the study drugs in the past 29 days
- Anticipated transfer within 72 hours to a non-study hospital
- Severe co-morbidity with life expectancy < 3 months
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 of Care (SoC)Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients. | Other | Remdesivir + SoC, Standard of Care (SoC) |
| RemdesivirRemdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first | Drug | Remdesivir + SoC |
Primary outcome
Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
Time frame: at day 15
WHO 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 ECMO; 7. Death
11 secondary outcomes
Time to an improvement of one category from admission using the 7-point ordinal scale
Time frame: up to 29 days
Mortality: 28 days mortality; in-house mortality
Time frame: up to 29 days
Hospital stay: Duration of hospital stay due to COVID-19
Time frame: up to 29 days
Oxygen: Need of, time to first receiving and duration of oxygen
Time frame: up to 29 days
Intensive care: Need of, time to first receiving and duration of intensive care
Time frame: up to 29 days
Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation
Time frame: up to 29 days
ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation
Time frame: up to 29 days
Superinfections, assessed with pathogen testing
Time frame: up to 29 days
Kidney failure
Time frame: up to 29 days
Myocardial failure
Time frame: up to 29 days
Multiple organ failure
Time frame: up to 29 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
Tobias Welte, MD, Prof. principal investigator
Hannover Medical School
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Remdesivir in people with SARS-CoV-2 Infection and COVID-19, run by Professor Dr. Bernd Mühlbauer at 4 sites in Germany.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement of clinical status on the ordinal 7-point severity-scale at day 15. (time frame: at day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2024.