SARS-CoV-2 serology in HIV PrEP users during the COVID-19 pandemic: THE PREP-CO STUDY

To investigate to prevalence and seroconversion rate of SARS-CoV-2 antibodies in a German cohort of MSM using HIV PrEP, Germany, over a time period of one year following the first outbreak of the covid pandemic.

DRKS link

Study Overview

Study nameSARS-CoV-2 serology in HIV PrEP users during the COVID-19 pandemic: THE PREP-CO STUDY
ProjectPrEP-Co
Sources of Monetary or Material SupportInstitutional budget, no external funding (budget of sponsor/PI)
Region(s)Germany
Location(s)Munich
Primary outcomeSeroconversion rate of SARS-CoV-2 antibody during one year of follow-up.
Secondary outcome[Pointprevalence of SARS-CoV-2 antibodies at baseline. Pointprevalence of SARS-CoV-2 antibodies at follow-up visits. correlation of the seroprevalence and/or seroconversion of SARS-CoV-2 positivity with sexual behaviour and other sexual transmitted diseases (STDs), such as syphilis, N. gonococcae, M. genitalium, C.trachomatis or HIV.]
Diagnostic test(s) used
  • SARS-CoV-2 Detection Kit , YHLO Biotech (Shenzhen, China)
Study population N300
Principal InvestigatorChristoph Spinner , Rechts der Isar Hospital, Department for Internal Medicine II , christoph.spinner @ mri.tum.de
Team members
  • Simon Weidlich, Study Coordinator, Rechts der Isar Hospital, Department for Internal Medicine II
Period2020-05-18 till ongoing
Study start2020-05-18
First results expected2021-03-31

Study metadata

{
   "abbreviation": "PrEP-Co",
   "draft": false,
   "iscjklanguage": false,
   "lastmod": "2021-03-12T09:43:51+01:00",
   "recruitment": {
     "country": [
       "Germany"
     ],
     "group": "general population",
     "location": [
       {
         "latitude": 48.1374859,
         "longitude": 11.6008283,
         "place_name": "Munich"
       }
     ],
     "type": "multicener diagnotic trial"
   },
   "study_dates": {
     "sample_end": "ongoing",
     "sample_start": "2020-05-18",
     "study_first_results": "2021-03-31",
     "study_start": "2020-05-18"
   },
   "study_info": {
     "diagnostic_test": [
       {
         "address": "Shenzhen, China",
         "antibody_classes": [
           "IgG",
           "IgM"
         ],
         "company": "YHLO Biotech",
         "product": "SARS-CoV-2 Detection Kit"
       }
     ],
     "funding_sources": "Institutional budget, no external funding (budget of sponsor/PI)",
     "primary_outcomes": "Seroconversion rate of SARS-CoV-2 antibody during one year of follow-up.",
     "secondary_outcomes": [
       "Pointprevalence of SARS-CoV-2 antibodies at baseline.",
       "Pointprevalence of SARS-CoV-2 antibodies at follow-up visits.",
       "correlation of the seroprevalence and/or seroconversion of SARS-CoV-2 positivity with sexual behaviour and other sexual transmitted diseases (STDs), such as syphilis, N. gonococcae, M. genitalium, C.trachomatis or HIV."
     ]
   },
   "study_numbers": {
     "study_population": 300
   },
   "study_pi": {
     "email": "christoph.spinner @ mri.tum.de",
     "institution": "Rechts der Isar Hospital, Department for Internal Medicine II",
     "name": "Christoph Spinner",
     "role": "Professor"
   },
   "team": [
     {
       "institution": "Rechts der Isar Hospital, Department for Internal Medicine II",
       "name": "Simon Weidlich",
       "position": "Medical Director Assistant",
       "role": "Study Coordinator",
       "title": "Priv.-Doz. Dr."
     }
   ],
   "title": "SARS-CoV-2 serology in HIV PrEP users during the COVID-19 pandemic: THE PREP-CO STUDY"
 }