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Corona Virus InfectionPhase 2RES-Q-HRNCT04681430

Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

A Phase 2 study testing Convalescent plasma and Camostat Mesilate in people with Corona Virus Infection and SARS-CoV-2 Infection, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

Completed

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

Official record
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Trial summary

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Convalescent plasma and Camostat Mesilate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
6 sitesGermany
Study dates
8 Jan 2021to 29 Oct 2021
Phase
Phase 2
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

  • Individuals (female, male, diverse) ≥ 18 years with SARS-CoV-2 infection, confirmed by PCR before study enrollment
  • SARS-CoV-2 positive PCR ≤ 3 days old (date of NP swab)
  • Presence of ≥ 1 SARS-CoV-2 typical symptom (fever, cough, shortness of breath, sore throat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms, exanthema) and symptom duration <= 3 days.
  • Ability to provide written informed consent
  • Presence of at least one of the following criteria:
  • Patients > 75 years
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  • Patients > 65 years with at least one other risk factor (BMI >35 kg/m2, coronary artery disease, chronic kidney disease (CKD) with glomerular filtration rate (GFR) <60 ml/min but >= 30 ml/min, diabetes mellitus, active tumor disease)
  • Patients with a BMI >35 kg/m2 with at least one other risk factor (CAD, CKD with GFR <60 ml/min but >= 30 ml/min, diabetes mellitus, active tumor disease)
  • Patients with a BMI >40 kg/m2
  • Patients with chronic obstructive pulmonary disease (COPD) and/or pulmonary fibrosis

Who cannot join

  • Age <18 years
  • Unable to give informed consent
  • Pregnant women or breast-feeding mothers
  • Previous transfusion reaction or other contraindication to a plasma transfusion
  • Known hypersensitivity to camostat mesylate and/or severe pancreatitis
  • Volume stress due to CP administration would be intolerable
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  • Known IgA deficiency
  • Life expectancy < 6 months
  • Duration SARS-CoV-2 typical symptoms > 3 days
  • SARS-CoV-2 PCR detection older than 3 days
  • SARS-CoV-2 associated clinical condition >= WHO stage 3 (patients hospitalized for other reasons than COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria).
  • Previously or currently hospitalized due to SARS-CoV-2
  • Previous antiviral therapy for SARS-CoV-2
  • alanine aminotransferase (ALT) or aspartate transferase (AST) > 5 times upper limit of normal (ULN) at screening
  • Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from the trial)
  • Chronic kidney disease with GFR < 30 ml/min
  • Concurrent or planned anticancer treatment during trial period
  • Accommodation in an institution due to legal orders (§40(4) AMG).
  • Any psycho-social condition hampering compliance with the study protocol.
  • Evidence of current drug or alcohol abuse.
  • Use of other investigational treatment within 5 half-lives of enrollment is prohibited
  • Previous use of convalescent plasma for COVID-19
  • Concomitant proven influenza A infection
  • Patients with organ or bone marrow transplant in the three months prior to Screening Visit

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Klinikum Dortmund

    Dortmund, North Rhine-Westphalia, 44137

  • Universitätsklinikum Düsseldorf Klinik für Hepatologie und Infektiologie

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV

    Frankfurt am Main, Hesse, 60590

  • Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München

    München, Bavaria, 81675

Other trials in Germany

About this study

Official title: Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

Read the detailed description

The novel coronavirus designated SARS CoV-2, and the disease caused by this virus designated COVID-19. No treatment is available for early disease stages and non-hospitalized patients to date. This trial focusses on SARS-CoV-2 positive patients with pre-existing risk factors for a moderate or severe COVID-19 disease course. This study is a 4-arm, multicenter, randomized, partly double-blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. Camostat mesylate acts as an inhibitor of the host cell serine protease TMPRSS2 and prevents the virus from entering the cell. Convalescent plasma (CP) represents another antiviral strategy in terms of passive immunization. The working hypothesis to be tested in the RES-Q HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression.

Being tested
Convalescent plasma, Camostat Mesilate, Placebo for Camostat Mesilate, Standard of Care (SoC)
Keywords
SARS-CoV-2, Covid-19, camostat mesilate, reconvalescent plasma, TMPRSS2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

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

  • Convalescent plasmaBiological

    transfusion of convalescent plasma (CP) with neutralizing antibodies against anti-SARS-CoV-2 ((titer of at least 1:160)

  • Camostat MesilateDrug

    Tablets over 7 days, daily dose of 600 mg split into 3 doses

  • Placebo for Camostat MesilateDrug

    Placebo Tablets over 7 days, split into 3 doses

  • Standard of Care (SoC)Other

    Control Arm for convalescent plasma (CP)

Study groups in NCT04681430
Study groupRoleWhat they receive
convalescent plasma (CP)ExperimentalAdministration of 2 units of CP (neutralizing anti-SARS-CoV-2 antibody titer of at least 1:160) on day 1
Receives: Biological: Convalescent plasma
Standard of CareOtherStandard of care allowed
Receives: Other: Standard of Care (SoC)
Camostat MesilateExperimentalTablets 600 mg per day in 3 doses over 7 days
Receives: Drug: Camostat Mesilate
Placebo camostatPlacebo comparatorPlacebo Tablets in 3 doses over 7 days (blinded)
Receives: Drug: Placebo for Camostat Mesilate

What is being measured

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

  1. WHO ordinal Covid-19 scale up to day 28

    The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28

    Measured: up to and including day 28

Secondary outcomes (25)

  1. Cumulative number WHO categories 4b-8

    Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8

    Measured: day 8, day 14, day 56 and day 90

  2. Cumulative number WHO categories 3-4a

    Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a

    Measured: day 8, day 14, day 28, day 56 and day 90

  3. Not hospitalized

    Cumulative number of participants not hospitalized at day 90

    Measured: at day 90

  4. All-cause mortality

    All-cause mortality at day 90

    Measured: at day 90

  5. Reinfection

    Number of patient with SARS-CoV-2 reinfection up to day 90

    Measured: up to day 90

  6. Secondary sclerosing cholangitis (SSC)

    Number of patient with secondary sclerosis cholangitis at day 90

    Measured: at day 90

  7. chronic pulmonary disease as sequelae from COVID-19

    Number of patient with COVID-19 associated chronic pulmonary disease

    Measured: at day 90

  8. patients with remdesivir treatment

    The proportion of patients with remdesivir therapy

    Measured: up to day 90

  9. COVID-19 WHO status of patients at start of remdesivir treatment

    The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

    Measured: up to day 90

  10. patients with dexamethasone treatment

    The proportion of patients on dexamethasone therapy

    Measured: up to day 90

  11. COVID-19 WHO status of patients at start of dexamethasone treatment

    The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment

    WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death

    Measured: up to day 90

  12. resolution of COVID-19 symptoms

    Time to resolution of COVID-19 related symptoms (e.g. fever)

    Measured: until day of resolution up to day 90

  13. negative SARS-CoV-2-PCR test

    Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)

    Measured: until day of first negative test up to day 90

  14. Oxygen therapy

    Duration of oxygen therapy (in days)

    Measured: number of days with oxygen therapy up to day 90

  15. COVID-19 pneumonia

    Frequency of occurrence of COVID-19 pneumonia

    Measured: up to day 90

  16. Percentage of participants requiring mechanical ventilation

    Percentage of participants in each group with need for mechanical ventilation

    Measured: up to day 90

  17. Number of ventilation days per participant up to day 90

    Number of ventilation days per participant up to day 90

    Measured: up to day 90

  18. hospital stay and intensive care

    Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)

    Measured: up to day 90

  19. Mortality

    All-cause mortality at day 28

    Measured: at day 28

  20. SAEs

    Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up

    Measured: up to day 90

  21. Grade 3/4 AEs

    Cumulative incidence of grade 3/4 Adverse Events (AE) per group

    Measured: up to day 90

  22. SARS-CoV-2 antibody IgA concentrations

    SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90

    Measured: on day 8, day 14, day 90

  23. SARS-CoV-2 antibody IgG concentrations

    SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90

    Measured: on day 8, day 14, day 90

  24. SARS-CoV-2 neutralizing antibody titers

    SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90

    Measured: on day 8, day 14, day 90

  25. Plasma treatment screening failures

    Number of screening failures due to the lack of a suitable plasma preparation

    Measured: up to day 8 (End of treatment)

Timeline

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

  1. First posted23 Dec 2020
  2. Study start8 Jan 2021
  3. Primary completion29 Oct 2021
  4. Study completion29 Oct 2021

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a multicenter trial that will be conducted in approx. 10 - 15 centers in Germany. At each center, patients will be randomized into four groups: two treatment groups and two control groups. The randomization rate in this study is two to one (2:1) in favor to therapy, i.e. included patients have twice the chance to receive interventional therapy than placebo / SoC.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681430
Sponsor's protocol ID
RES-Q-HR
Other IDs
2020-004695-18
Acronym
RES-Q-HR
Status last verified
Feb 2022
First submitted
17 Dec 2020
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Keitel V, Jensen B, Feldt T, Fischer JC, Bode JG, Matuschek C, Bolke E, Budach W, Plettenberg C, Scheckenbach K, Kindgen-Milles D, Timm J, Muller L, Kolbe H, Stohr A, Calles C, Hippe A, Verde P, Spinner CD, Schneider J, Wolf T, Kern WV, Nattermann J, Zoufaly A, Ohmann C, Luedde T; RES-Q-HR Trial Team. Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):343. doi: 10.1186/s13063-021-05181-0.

    PubMed 34001215

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Convalescent plasma and Camostat Mesilate in people with Corona Virus Infection and SARS-CoV-2 Infection, run by Heinrich-Heine University, Duesseldorf at 6 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 10 inclusion and 24 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

WHO ordinal Covid-19 scale up to day 28 (time frame: up to and including day 28). 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 NCT04681430, which also lists 1 linked publication.

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 10 Feb 2022.

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